Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

All Drugs and Chemicals

Fluorodeoxyglucose F18

Positron Emission Tomography

Alexander McEwan, MD

18F-fluorodeoxyglucose (18F-FDG) has been approved by many regulatory agencies world-wide and is in widespread use in the United States, Japan and Europe. In the United States, 18F-FDG scanning in oncology is approved for federal healthcare reimbursement for non-Hodgkin's lymphoma, Hodgkin's disease, colorectal cancer, lung cancer, oesophageal cancer, melanoma, head and neck cancer and breast cancer. It has general applications in all areas where abnormal glucose metabolism may be present including in circumstances such as differentiating the tumour from scar tissue; evaluating the presence of the tumour in light of rising tumour markers and normal imaging techniques; and assessing response to therapy where other techniques are deemed to be unhelpful. Current literature suggests that functional imaging with 18F-FDG Positron Emission Tomography (PET) may play an important role in the imaging evaluation of patients with soft tissue sarcoma, including guiding biopsy; detecting local recurrence at sites of tumour resection; detecting metastatic disease; predicting and monitoring response to therapy; and assessing for prognosis. In appropriate situations, it is possibly the most effective diagnostic strategy. However, due to the low incidence of these tumours, prospective studies with large multicenter patient groups will be essential to define the exact diagnostic role of 18F-FDG PET in this clinical setting.

Background: Positron Emission Tomography (PET) is a specialized nuclear medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity. The most common of these tracers, 18F-2-fluoro-2-deoxyglucose (FGD), an analog of glucose, is used to determine abnormal glucose metabolism in tumours and other sites. FDG has general applications where abnormal glucose metabolism may be present such as differentiating tumour from scar tissue, evaluating the presence of tumour in light of rising tumour markers and normal morphological imaging, and assessing response to therapy.

The Cross Cancer Institute has been funded to establish a PET centre and research program to prove the effectiveness of PET scanning in the Canadian health care environment and validate the data that have been developed in other jurisdictions in specific oncologic indications. A cyclotron has been installed at the Cross Cancer Institute which produces 18F-fluoride that is used in the automated synthesis of FDG. The three PET scanners in the Department of Oncologic Imaging will be used for this protocol.

Objectives:

Primary - establish the general utility and value of FDG-PET imaging in patients with known or suspected soft tissue sarcoma.

Secondary - demonstrate the safety of FDG-PET imaging by documentation of adverse events; determine whether the number of subjects available for study at the Cross Cancer Institute is sufficient to achieve statistically significant results; determine the feasibility of extending this study to a larger multicenter design.

Study Design: The proposed trial will be a Phase II, diagnostic imaging, open label, single site clinical trial. The patient population will consist of patients with known or suspected soft tissue sarcoma. This will also be a pilot study to test the feasibility of extending this trial to a larger multicenter design in view of increasing sample size and strengthening conclusions about safety and effectiveness of FDG-PET imaging in this population.

With each scan, the patient will receive a single IV injection of FDG. Initial imaging will be conducted 60 minutes after an average injection of 200-300 MBq of FDG (dose is dependent on which scanner is used and patients' weight). The images will then be examined by an experienced nuclear medicine physician and the location and intensity of abnormal FDG uptake will be reported. The referring physician will then correlate the findings with the results of clinical examinations and conventional imaging.

Statistical Analysis: The investigators will calculate the positive predictive value (PPV) of the FDG scans. They also intend to evaluate the percentage of patients in which the FDG scan outcome affected patient management.

Stopping Rules: The subject is free to withdraw at any time. The investigator also has the right to withdraw a subject from the study in the event of intercurrent illness or other reasons concerning the health or well being of the subject, or in case of lack of cooperation. Should a subject decide to withdraw or the investigator decide to withdraw the subject after administration of FDG, all efforts will be made to complete and report follow-up observations as thoroughly as possible providing consent is still valid. A complete final evaluation at the time of the subject's withdrawal is to be made with an explanation of why the subject is withdrawing or being withdrawn from the study. If the reason for withdrawing a subject from the study is a specific event or an abnormal laboratory test result, the event or test result must be recorded as an adverse event and entered into the Case Report Form.

Data Safety Monitoring Committee: Preliminary data will be analyzed for safety and effectiveness on a yearly basis until the study ends.

Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Soft Tissue Sarcoma

A Phase II Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Soft Tissue Sarcoma

Cross Cancer Institute

AHS Cancer Control Alberta

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

All patients who give their consent for this study will participate in the test group and will therefore receive the injection with 18F-FDG and images (PET / CT) will be made of the resection piece.

In this study, the high-resolution PET-CT system will be used to evaluate the cutting edges after tumor resection. The goal is to evaluate the distance of the tumor cells from the cutting edges of the surgical piece. The patient receives an intravenous injection of radiolabeled sugar (18F-FDG). 18F-FDG is the standard PET tracer for diagnostic PET-CT research. This standard dose will always be calculated according to the formula: 3.7 x body weight + 37 Mbq.

Positron Emissie Tomografie - Computer Tomografie

Frederik Berrevoet, MD-PhD

One of the main risks for recurrence in patients with pancreatic cancer is incomplete surgery of the primary tumor. During the operation, the surgeon bases himself for this on imaging and peroperative vision. Unfortunately, this is not always sufficient and it is sometimes determined after surgery that the cutting edges are not free of tumor cells. Research has already shown that there is a significantly better survival when a margin of at least 1 mm is maintained between the macroscopic tumor and the cut surface. It is therefore important to remove the tumor as completely as possible without the risk of residual tissue and with a sufficiently wide margin.

The only method that can currently be used to determine during surgery if the tumor has been completely removed is to use "frozen sections". With a frozen section, the surgical piece is sent to the pathology department during the operation, where sections are taken from the edges. These are frozen in nitrogen and immediately viewed by a pathologist. If the cut edge is positive, this will be passed on to the surgeon who will take a wider resection if possible. Unfortunately, this method is time consuming and labor intensive. The evaluation of these cut edges on frozen section is not easy and requires a lot of experience. The percentage of false negative reviews for frozen section is not high, but it is true that it is not non-existent either. In addition, it is not possible to evaluate all cleavage surfaces peroperatively. This is currently happening for the distal pancreatic cutting edge and the bile duct cutting edge, but not, for example, for the posterior pancreatic surface and for the surface of the groove in which the superior mesenteric vein runs.

The use of peroperative imaging in the form of 18F-FDG PET-CT scan of the tumor would be a clear asset for this. This would not only be faster than frozen sections, but also provide a full 3-dimensional image of the extracted specimen, which may provide more insights than 2D frozen sections. The ultimate goal of this study is to bring the high resolution PET-CT system into the operating theater. For example, during the operation, in the operating theater itself, it could be determined where residual tumor tissue would be present and then performed a wider resection in order to avoid a positive margin status.

This study will be conducted in patients undergoing surgery for pancreatic cancer removal. The aim of this study is to see whether all tumor tissue has been removed in this patient group during the removal of the tumor. This will be done with the help of a high resolution PET-CT (Positron Emission Tomography - Computer Tomography) system, developed by the Faculty of Engineering, UGent, and commercialized by Xeos (spin-off from Ghent University). This system is the compact (and transportable version) of the standard PET-CT and was initially developed for imaging small laboratory animals, typically mice, for which a particularly high resolution is required. In this study, the high-resolution PET-CT system will be used to evaluate the cutting edges after tumor resection. The goal is to evaluate the distance of the tumor cells from the cutting edges of the surgical piece.

The patient receives an intravenous injection of radiolabeled sugar (18F-FDG). 18F-FDG is the standard PET tracer for diagnostic PET-CT research. This standard dose will always be calculated according to the formula: 3.7 x body weight + 37 Mbq. The injection will be carried out by a trained "helper" under article 53.2 of the Royal Decree of 30/08/2001. This injection is always carried out under the responsibility of Dr. Kathia De Man or Dr. Bliede Van den Broeck as a recognized and licensed nuclear medicine doctor. The location of the injection will depend on the logistical possibilities of the day of operation. Due to the radioactive decay of the molecule, the optimal moment of injection of this radiolabeled sugar is best as short as possible before scanning the tumor. If possible, a "helper" will transport the radiolabelled sugar to the operating theater (OR) and the injection will be performed in the OR itself. If this option does not exist, the injection will be performed at the nuclear medicine department of UZ Gent, after which the injected patient will be immediately taken to the OR. Based on the natural decay of the radioactivity, the results of both injection times can be compared using the time of injection, injected dose and time of scan. The data collected during the study will allow to calculate post-hoc what the ideal dose of 18F-FDG is for this indication, i.e. the lowest possible dose for the patient, which can still be optimally measured by the scanner . The ALARA (as low as reasonably achievable) principle always applies.

The surgery to remove the pancreatic tumor follows the standard procedure. After removal, the surgical piece is first taken to the anatomopathology department. Frozen sections will be taken and analyzed directly for intake by tumor cells. Immediate feedback on this is given to the surgeon in the OR, as is done within the standard procedure. After taking the frozen sections, the rest of the specimen is taken to the "INFINITY" lab on the UZ Gent campus. Here a high-resolution PET-CT scan is performed on the surgical piece. After the PET-CT scan, the surgical piece is returned to the pathological anatomy department for further standard pathological evaluation. No information about the PET-CT results will be given to the surgeon during surgery so as not to interfere with the standard surgical procedure. The results of the high resolution PET-CT scan will be correlated post-hoc with the routine histopathological results of the tumor specimen, which is considered the gold standard.

Peroperative Assessment of Tumour Resection Margins Using High-resolution 18F-FDG-PET/CT in Pancreatic Adenocarcinoma

Peroperative Assessment of Tumour Resection Margins Using High-resolution 18F-FDG-PET/CT in Pancreatic Adenocarcinoma, a Pilot Study: IMA PancreasCA (BC-05923)

first PET imaging after resection for visiuallazation of the proximity of the leasion then frozen section of the cutting edge to astablising the same result and comparing the results from PET and frozen section.

University Hospital, Ghent

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Positron Emission Tomography Imaging

Breast cancer affects many women. One of the places to which it can spread is the lymph glands under the arm. The type of treatment offered to patients often will depend on whether those lymph glands have cancer in them or not. For this reason, a standard recommendation is that women with breast cancer have these lymph glands removed with surgery. This cancer causes side effects including numbness, pain, decreased ability to move the arm and arm swelling. A new type of surgery which looks only at the first gland that a cancer drains to (sentinel node biopsy) may help to avoid having to remove the glands under the arm. Also, a new way of imaging the glands under the arm called Positron Emission Tomography (PET) scanning may also give a better idea of the chance that these glands have cancer in them. This study is determining whether PET scans before surgery and sentinel node biopsy can decrease the need for a complete axillary dissection.

1.0 Introduction

Breast cancer is the most common cancer in North American women. It is estimated that one in 8 American women will develop breast cancer during her lifetime. Surgical treatment has evolved from radical mastectomy to breast conservation, and systemic treatment has become increasingly important. The presence or absence of lymph node metastases is the most important prognostic factor used to determine type of systemic treatment necessary. Axillary dissection however, carries with it the risk of nerve injury, lymphedema, decreased arm motion and seroma formation. Clinical examination, ultrasound, CT scanning and MRI of the axilla are not sensitive or specific enough to eliminate the need for axillary dissection. Sentinel node biopsy (SNB) can predict the pathologic status of the axilla and theoretically could differentiate patients into those with positive node biopsies who require full dissection versus those who are negative and do not. Frozen section of the sentinel node is inaccurate and therefore SNB positive patients would require two surgical procedures. Positron Emission Tomography (PET) scanning of the axilla has been reported to have a high sensitivity and specificity and if used prior to surgery may guide the surgeon in determining the need for full axillary dissection versus SNB alone. PET scanning has also been reported to identify unsuspected distant metastases not found on standard staging examinations. This study will investigate the use of PET scanning in conjunction with SNB and results of both modalities will be correlated with histologic results of axillary dissection.

2.0 Objectives

There are no reports describing results of a similar study. By performing a properly constructed clinical trial in T1 - 3 N0 breast cancer patients, the question of whether PET scanning will make a difference to patient management can be answered. The hypothesis of this study is therefore, that a PET scan prior to surgery will facilitate staging both locally (axilla) and distant and will help the surgeon determine whether to do SNB or axillary dissection.

2.1 Primary Objective: To determine whether preoperative PET imaging combined with sentinel node biopsy can accurately identify nodal status. This would be most important in patients with a negative PET scan and negative sentinel nodes. If the combination of these tests was found to have a high negative predictive value for nodal metastases, full axillary dissection could be avoided.

2.2 Secondary Objectives:

* Assess pattern of lymph node drainage using lymphoscintigraphy.
* Assessment of size limitations of PET scanning in metastatic lymph nodes.
* Assessment of primary tumor size and evidence of multifocality as compared to preoperative imaging (mammography +/- ultrasound).
* The incidence of unsuspected distant metastases and frequency with which treatment was changed as a result of the PET scan would also be determined.

3.0 Materials and Methods

3.1 Patient Population: Pre and post menopausal women with clinical T1-3 N0 breast cancer are eligible. All will have biopsy proven breast carcinoma. Positive core or fine needle aspiration biopsies will be obtained in all patients. Core biopsies are preferred. Excisional biopsies are not allowed. Patients must not be pregnant or lactating and must not have had prior malignancy. Diabetic patients are ineligible. An informal survey of 8 patients from Calgary indicates that all 8 would be willing to travel to Edmonton for their PET scan. (Personal communication from Dr. Mews).

3.2 Preoperative Imaging: All patients will have preoperative mammography +/- ultrasound of the breast. Patients eligible for and consenting to the study will be referred to the Cross Cancer Institute by their surgeons and will have preoperative PET scanning. Imaging will be completed within seven days prior to surgery. Once a PET scanner becomes available in Calgary, the scans will be done there. Potential sites of distant metastases identified by PET scan will be imaged further and if necessary, possible biopsies will be obtained to confirm the diagnosis.

3.3 Surgery: Dr. Kelly Dabbs from Edmonton and Dr. Daphne Mew from Calgary will be the surgeons involved. They have proven experience in doing SNB's. At the time of surgery, sentinel node biopsy using both blue dye and colloid will be performed followed by level I/II axillary dissection. The patients may have either segmental resection or mastectomy.

3.4 Pathology: The sentinel node will be assessed by H\&E as well as immunohistochemistry as per standard protocol. Measurements of primary tumor size, size of axillary metastases and size of in situ component will be documented. All pathology will be reported by Dr. J. Danyluk, Dr. R. Berendt and Dr. F. Alexander.

3.5 Outcome Analysis: Patients with positive axillary nodes on dissection and positive SNB and/or PET will be considered true positive (TP) for that modality. A negative axillary dissection and negative PET and/or SNB will identify the true negative (TN) group. A positive axillary dissection and negative PET and/or SNB will identify the false negative (FN) subgroup. A negative axillary dissection and positive PET and/or SNB will identify the false positive (FP) subgroup. Sensitivity (TP/TP + FN) and specificity (TN/TN + FP) will be determined. If patients do not have successful sentinel node surgery or PET scanning, they will be included in the analysis of the individual modality which was successful.

3.6 Statistics: In order to have an adequate number of node positive patients to test sensitivity an overall total of 240 patients is required. The proportion of patients who are node positive is estimated to be 0.35. A sample of 240 is expected to contain 84 node positive patients and the probability that at least 72 of the 240 patients are node positive is 0.95. The subsample of 72 node positive patients is sufficient to perform a one-sided test of equivalence for a target sensitivity of 0.80 and an allowable difference of 0.10 with significance level of 10% and power of 80%.The 168 node negative patients from the 240 total permit a one-sided test of equivalence for which the target specificity is 0.95 and the allowable difference is 0.05 with significance level of 5% and power of 90%.43

Study of Fluorodeoxyglucose (FluGlucoScan) in Patients With Breast Cancer: Correlation With Histologic Findings of Sentinel Node Biopsies and Axillary Dissection

A Phase II Study of Fluorodeoxyglucose (FluGlucoScan) in Patients With Breast Cancer: Correlation With Histologic Findings of Sentinel Node Biopsies and Axillary Dissection

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

Etoposide

Cyclophosphamide

Rituximab

Cisplatin

Etoposide phosphate

Mesna

Standard R-CHOP chemotherapy every 21 days X 2 Cycles followed by PET/CT scan. If scan is determined negative for disease intensity patient receives 4 more cycles R-CHOP (total 6 cycles R-CHOP)

Assigned interventions: Drug: R-CHOP (Rituximab, Cyclophosphamide, Etoposide, Cisplatin, Mesna, G-CSF 6 - 21 DAY Cycles of R-CHOP

Standard R-CHOP chemotherapy every 21 days X 2 Cycles followed by PET/CT scan. If scan is determined positive for disease intensity the patient receives one cycle or R-DICEP/R-BEAM the autologous blood stem cell transplantation.

Assigned Interventions: Procedure/Surgery: Autologous Blood Stem Transplantation 2 CYCLES OF R-CHOP + R-DICEP/R-BEAM FOLLOWED BY AUTOLOGOUS BLOOD STEM CELL TRANSPLANTATION

2 CYCLES OF R-CHOP + R-DICEP/R-BEAM FOLLOWED BY AUTOLOGOUS BLOOD STEM CELL TRANSPLANTATION

Autologous Blood Stem Transplantation

R-CHOP

Douglas Stewart, M.D.

The purpose of this study is to evaluate:

1. whether an imaging test called a PET (Positron emission tomography) scan performed after two cycles of standard chemotherapy is able to identify patients who have a high cure rate after completing standard chemotherapy alone; and
2. whether high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) when used in combination with an antibody called Rituximab results in high cure rates for those patients predicted to do poorly with standard chemotherapy by the PET scan.

BACKGROUND AND RATIONALE:

Although the addition of Rituximab anti-CD20 monoclonal antibody therapy to standard CHOP chemotherapy (R-CHOP) results in a 15-20% increase in absolute EFS rate over CHOP alone for DLBCL patients, it is likely that 40-50% of patients with poor prognosis DLBCL will not be cured by R-CHOP. High dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) has been shown to salvage a substantial proportion of patients with relapsed DLBCL. A meta-analysis of randomized controlled trials comparing standard-dose chemotherapy (SDCT) alone to SDCT followed by HDCT/ASCT as initial treatment for poor prognosis DLBCL demonstrated a significant benefit for HDCT over SDCT in terms of EFS and OS. A single centre prospective phase II study was conducted in Calgary to assess feasibility, toxicity, and efficacy of two cycles of HDCT following just one cycle of CHOP induction therapy for patients under 65 years of age who were diagnosed with aggressive histology lymphoma and 2-3 Age Adjusted International Prognostic Index (AAIPI) risk factors. The study was conducted prior to the widespread use of Rituximab plus CHOP (R-CHOP). The treatment protocol involved one cycle of standard dose CHOP followed by one cycle of dose-intensive cyclophosphamide 5.25 g/m2, etoposide 1.05 g/m2, cisplatin 105 mg/m2 (DICEP), then autologous blood stem cell collection, followed by one cycle of high dose BCNU 300 mg/m2, etoposide 800 mg/m2, Ara-C 1600 mg/m2, melphalan 140 mg/m2 (BEAM) and autologous stem cell transplantation (ASCT) and radiotherapy to prior bulk. With a median follow up of 49 months, 4 year event free (EFS) and overall survival (OS) rates for the 55 patients accrued to the study were 72% (95% CI=60-84%) and 79% (95% CI=69-90%), respectively.

The two major advances in lymphoma management that have occurred since the design of our CHOP-DICEP-BEAM/ASCT phase II study are the addition of Rituximab anti-CD20 monoclonal antibody therapy to chemotherapy (as described above), and the use of FDG-PET functional imaging/response assessment. Several studies have reported the strong correlation of early response assessment using FDG-PET with PFS and OS following standard chemotherapy for aggressive NHL. In one of the largest, best designed studies, PET-negativity following 2 cycles of RCHOP was associated with higher 2-year estimates of EFS (82% vs 43% , p \< .001) and OS (90% vs 61%, p = .006). The incorporation of Rituximab and PET-guided HDCT/ASCT into our intensive chemotherapy protocol may lead to further improvements in EFS while decreasing the overall need for HDCT/ASCT by targeting those patients destined to fail R-CHOP by early PET-based response assessment.

STUDY OBJECTIVES:

1. To determine if negative FDG-PET imaging following 2 cycles of R-CHOP chemotherapy is able to identify a group of patients with excellent prognosis (80% 3-year EFS) following standard 6 cycles of R-CHOP chemotherapy alone.
2. To determine if a group of patients with positive FDG-PET imaging following 2 cycles of R-CHOP chemotherapy are able to achieve excellent outcome (80% 3-year EFS) following intensive chemotherapy with R-DICEP and R-BEAM/ASCT.
3. To determine if PET-guided R-DICEP and R-BEAM/ASCT is feasible and associated with acceptable toxicity rates in a multi-centre study.

STUDY DESIGN:

INCLUSION CRITERIA:

1. Give written informed consent
2. Age 18-65 years
3. Histological diagnosis of Diffuse Large B-cell Lymphoma including:

   1. Diffuse Large B-cell
   2. Immunoblastic B-cell
   3. Primary Mediastinal Diffuse Large B-cell
   4. T-cell Rich, Diffuse Large B-cell
   5. Anaplastic Large B-Cell
   6. Diffuse Large B-cell with areas of follicular lymphoma in same biopsy
4. No central nervous system involvement by lymphoma
5. No more than 1 prior cycle of R-CHOP chemotherapy
6. At least 1 adverse International Prognostic Index factor at diagnosis:

   a. Age \> 60 years b. ECOG performance status 2-4 c. Elevated serum LDH level d. More than 1 extranodal site involved by lymphoma e. Stage 3 or 4
7. Adequate organ function:

   1. Cardiac: LVEF \>45%
   2. Pulmonary: FVC, FEV1 and DLCO \>50% predicted
   3. Renal: creatinine \<120µmol/L unless caused by ureteric obstruction from lymphoma
   4. Liver: ALT, AlkP, Bilirubin \<3 x upper limit of normal unless caused by biliary tract obstruction from lymphoma

      EXCLUSION CRITERIA:

      1. Histological diagnosis other than Diffuse Large B-cell Lymphoma 2. Pregnant or lactating females 3. Concurrent use of other anti-cancer therapies 4. Other serious co-morbid illness that would compromise study participation. 5. Prior malignancy unless non-melanoma skin cancer, carcinoma in-situ of the cervix (CIN) or breast, or malignancy treated more than 5 years previously with no evidence of recurrent disease since initial treatment.

      6. More than 1 prior cycle of Rituximab, cyclophosphamide, or doxorubicin. 7. Prior HDCT/ASCT or prior radiotherapy.

      STUDY ENDPOINTS

      Primary:

      • 3 year EFS for patients receiving 6 cycles R-CHOP (PET-negative response) and for patients receiving RCHOP x2 followed by R-DICEP then R-BEAM/ASCT (PET-positive response)

      Secondary:

      • Complete and Partial Response Rates

      • PET/CT response rates following RCHOP x 2 cycles

      • Overall Survival
      * Safety (type, frequency, severity, and relationship of adverse events to study treatment)

      STUDY DURATION: Three years TOTAL SAMPLE SIZE: 70-80 patients

      DOSING REGIMEN(S):



1. Induction: Standard R-CHOP chemotherapy q21days x 2 cycles

   R-CHOP x 2 cycles q21days:

   Rituximab 375mg/ m2 IV day 1 Cyclophosphamide 750mg/ m2 IV day 1 Adriamycin 50mg/ m2 IV day 1 Vincristine 1.4mg/ m2 (max 2mg) IV day 1 Prednisone 100mg po days 1-5
2. FDG-PET/CT imaging between days 10-15 following R-CHOP cycle #2.

Sites of disease will be scored for intensity based on the following scale:

1. Absent
2. Minimal (low grade but greater than in regional lymph nodes of similar size or surrounding interstitial tissues)
3. Low (readily visible but less than liver)
4. Medium (comparable to liver)
5. High (greater than liver)

   Interim post therapy scans will be considered as negative (showing a favorable response) if no more than one site shows an intensity score of greater than 3.

   The treatment protocol will be dictated by the result of the interim FDG-PET/CT scan following 2 cycles of R-CHOP chemotherapy as follows:
   1. If FDG-PET scan negative: 4 more cycles R-CHOP (total 6 cycles R-CHOP)
   2. If FDG-PET scan positive: one cycle of R-DICEP then within 5-8 weeks administer R-BEAM and autologous blood stem cell transplantation as outlined below:

      3) For PET-positive patients ONLY:

   R-DICEP CHEMOTHERAPY (begin 3-5 weeks following day 1 CHOP #2).

   ½NS+20meq KCL/L IV at 150ml/h start 19:00h day 1 then decrease to 75ml/h at 08:00am day 2, continue to day 5 Rituximab 375mg/m2 IV day 1 and 8 (day 1 on a Wednesday) Cyclophosphamide 1.75 g/ m2 d2,3,4 in 500ml D5W over 2 hrs Etoposide 350 mg/ m2 d2,3,4 in 1 L over 2 hrs daily Cisplatin 35 mg/m2 d2,3,4 in 500ml N/S +25g mannitol over 2 hrs Mesna 1.75g/m2 d2,3,4 by continuous infusion over 24 hrs G-CSF 300 (\<70kg), 480 (70-100kg), or 600mcg/d (\>100kg) SC from day 15 until apheresis completed

   AUTOLOGOUS BLOOD STEM CELL COLLECTION:

   Apheresis approximately day 20-22 of R-DICEP, after ANC\>5 x 109/L, platelets increasing \>50 x109/L , and peripheral blood CD34 count \>20 x106/L (if measurement available). Apheresis to proceed according to standards set at each study centre until at least 3x106CD34+ cells/kg have been collected (\>5x106 CD34+ cells/kg preferred).

   R-BEAM + Autologous Stem Cell Transplantation (5-8weeks post-d1 R-DICEP)

   Day - 6 Rituximab 375mg/m2 IV BCNU 300mg/m2 IV Day -5 to -2 Etoposide 100mg/m2 IV q12h x 8 doses Ara-C 200mg/m2 IV q12h x 8 doses Day -1 Melphalan 140mg/m2 IV Day 0 Stem Cell Infusion Day 14 Rituximab 375mg/m2 IV

FDG-PET-Stratified R-DICEP and R-Beam/ASCT For Diffuse Large B-Cell Lymphoma

FDG-PET-Stratified R-DICEP and R-BEAM/ASCT For Diffuse Large B-Cell Lymphoma

Hoffmann-La Roche

Dr. Douglas Stewart - Principal Investigator

Symptoms and General Pathology

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Inflammation

Alpha 1-Antitrypsin Deficiency

Alpha-1 Antitrypsin Deficiency

Micronutrients

Reproductive Control Agents

Vitamins

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Antioxidants

Dinoprost

Dinoprost tromethamine

Vitamin A

Retinol palmitate

Catalase

Alpha 1-Antitrypsin

Protein C Inhibitor

Tocopherol

Tocotrienol

Retinol

Oncological patients: lymphomas (Hodgkin's, DLBCL), breast and ovarian cancers, brain gliomas.

The number at most half as large as the patients' group, composed of healthy people at similar age and the same sex as patients.

The FDG PET/CT imaging will be performed as part of typical medical procedures related to the diagnosis and monitoring of cancers at the Oncology Center in Bydgoszcz, Poland

Patients

Paweł Sutkowy, PhD

The research aims to determine the parameters of oxidative stress and inflammatory processes and compare these parameters with the image obtained using positron emission tomography (PET) with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose (18F-FDG) integrated with computed tomography (CT) in the group of oncological patients.

FDG PET/CT is very sensitive imaging tool for the detection of neoplasms. Neoplasm tissue is characterized by a much higher level of metabolism than healthy tissues, therefore a 95% cases of use the method regard oncology. Fluorodeoxyglucose (FDG) is absorbed by patients' organism as glucose but it does not undergo metabolism. The increased degree of FDG accumulation in tissue means its higher metabolic activity. FDG accumulates in the tumor tissue and radiates enabling its detection but the substance has not been shown to be harmful to patient at doses used in the diagnostics.

Tumor formation is a multi-stage process in which the phases of initiation, promotion and progression are distinguished. Neoplastic transformation of healthy cells is associated with disturbances of the cell cycle caused by mutations of proto-oncogenes (activation of cell division) and/or suppressor genes (blocking cell division) and mutator genes (protecting the DNA against damage or its repairing) under the influence of various factors. Increasing data indicate that one of the most important factors initiating neoplasm are reactive oxygen species (ROS) and oxidative stress. Mechanisms responsible for induction of oxidative stress in cancer cells are not fully explained. It is known that they are closely related to inflammation, as well as intense cellular metabolism associated with continuous proliferation, mutations in the genetic material and dysfunctions in the mitochondrial respiratory chain.

In this study a number of markers of oxidative stress and inflammation are planned to be determined including: the activities of antioxidant and lysosomal enzymes, as well as concentrations of lipid peroxidation products and low molecular weight antioxidants. The PET/CT imaging will be performed as part of standard medical procedures related to the diagnosis and monitoring of cancer diseases at the Oncology Center in Bydgoszcz, Poland.

Venous blood collected from the basilic vein from the study participants into two vacuum test tubes only once (from patients during FDG PET-CT diagnosis): for full blood (K2EDTA) and blood serum (clot activator and gel separator).

Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.

Oxidative Stress and Inflammatory Processes in Selected Neoplasms in the Group of Oncological Patients Examined With the FDG PET/CT Method.

There is no the individual participant data (IPD) sharing plan.

Total antioxidant potential of blood serum in the participant

Positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose integrated with computed tomography

Nicolaus Copernicus University

Assistant professor

Gland and Hormone Related Diseases

Nervous System Diseases

Lung Neoplasms

Colorectal Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Brain Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Endocrine System Diseases

Positron Emission Tomography (PET) scan

Alexander McEwan, MB, MSc, MD, FRCP

Positron Emission Tomography (PET) is a specialised nuclear medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity. The most common of these radiolabeled tracers is 18F-fluorodeoxyglucose (18F-FDG), which is used to determine abnormal glucose metabolism in tumours and other sites. It has general applications in all areas where abnormal glucose metabolism may be present including in circumstances such as differentiating the tumour from scar tissue; evaluating the presence of the tumour in light of rising tumour markers and normal morphological imaging techniques; and assessing response to therapy where other techniques are deemed to be unhelpful. The Cross Cancer Institute (CCI) has recently been funded to establish a PET centre, and this study will prove the effectiveness of PET scanning in the Canadian health care environment and validate the data that have been developed in other jurisdictions in specific oncologic indications.

Background

Positron Emission Tomography (PET) is a specialised Nuclear Medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity. The commonest of these radiolabeled tracers is 18F-Fluorodeoxyglucose (18F-FDG), which is used to determine abnormal glucose metabolism in tumours and other sites. It has general applications in all areas where abnormal glucose metabolism may be present including circumstances such as differentiating tumour from scar tissue, evaluating the presence of tumour in the light of rising tumour markers and normal morphological imaging techniques and assessing response to therapy where other techniques are deemed to be unhelpful.

The Cross Cancer Institute has recently been funded to establish a PET centre that will establish a research programme to prove the effectiveness of PET scanning in the Canadian health care environment and validate the data that have been developed in other jurisdictions in specific oncologic indications.

Objectives

Primary Objectives - The objectives of the clinical trial are to (a) demonstrate the safety of 18F-FDG synthesised from cyclotron produced radiofluoride in the Coincidence Technologies automated synthesis unit (ASU) in the Edmonton PET Centre facility and (b) confirm the diagnostic effectiveness of 18F-FDG in subjects with known or suspected oncologic disease and to compare this with values published in the literature.

Secondary Objectives - The secondary objectives of the clinical trial are to confirm the general utility and value of 18F-FDG imaging of abnormal glucose metabolism in oncologic applications, particularly with respect to Canadian practice.

Study Design

The proposed clinical trial will be a combined Phase I/II, Phase III, extended Phase III (Phase I/II,III,exIII), diagnostic imaging, controlled, open label, single site, clinical trial in a broad cross-section of CCI patients, including patients with Hodgkin and non-Hodgkin lymphoma, colorectal cancer, breast cancer, melanoma, head and neck cancers, PRUNK, esophageal cancer, thyroid cancer, NSCLC, SCLC, neuroendocrine tumours, and patients with CNS tumours where conventional imaging methods have failed to yield a diagnostic answer.

Each patient will usually receive a single IV injection of 18F-FDG. Imaging will be conducted 30 to 60 minutes after an average injection of 200 - 300 MBq of 18F-FDG in hydrated, fasted patients. Images will be collected for 40 to 60 minutes in 5 - 7 body positions (total counts 5 to 15 million). For the Phase I/II study, images will be interpreted by a single experienced Nuclear Medicine physician with regard to normal physiological uptake of 18F-FDG. For the Phase III study, images will be interpreted independently by two experienced Nuclear Medicine physicians with regard to normal physiological uptake of 18F-FDG. The location and intensity of abnormal 18F-FDG uptake will be noted and correlated with clinical findings, surgical or biopsy results or with conventional imaging techniques, as available. The image review will be supplemented with access to clinical and conventional imaging data in the Phase I/II study. In the Phase III study all images will be reviewed independently by one physician blinded to all clinical data except the primary diagnosis and by one physician with access to all relevant clinical information. In the extended Phase III protocol the images will be interpreted by a single physician with access to relevant clinical information

Statistical Analyses

Sample Size

The Phase I/II stage will enroll 20 subjects without regard for tumour type. The Phase III stage will enroll approximately 300 subjects and the extended Phase III stage will enroll approximately 3000 subjects with the approximate distribution by tumour type as follows:

Tumour Type Phase III:Extended Phase III

* Brain 10:100
* Colorectal 33:330
* Breast 21:210
* Lung (NSCLC \& SCLC) 130:1300
* Lymphoma (Hodgkin's and non-Hodgkin's) 22:220
* Head \& Neck 16:160
* Neuroendocrine 10:100
* Thyroid 29:290
* Melanoma 15:150
* PRUNK 14:140

Within each cancer subgroup in the Phase III stage, where disease status confirmation is available, the sensitivity (true positive outcomes/true positive outcomes + false negative outcomes) and positive predictive value (true positive outcomes/true positive outcomes + false positive outcomes) will be calculated on a per patient basis. The general criteria for assessment of comparability is that the study group sensitivity percent and positive predictive value percent values have a difference of not less than 15 percent from the appropriately matched literature values. For subgroups with significant patient numbers statistical analysis of comparability will be undertaken.

Criteria for Evaluability of Study Subject Data All subjects enrolled in the Phase I/II stage of the trial will be evaluated for safety. All subjects enrolled in the Phase III and extended Phase III study will be evaluated for safety and efficacy.

Study Population

Number of Subjects to be Studied Phase I/II stage: \~ 20 Phase III stage: \~ 300 Extended Phase III stage: \~ 3000 Some variation in the patient numbers studied is anticipated in the Phase III and extended Phase III depending on local conditions and timing.

Inclusion Criteria for Selection of Study Subjects

Patients will be included in the study if they meet all of the following general criteria.

1. Male or female.
2. Known or suspected primary or metastatic tumours.
3. Age greater than or equal to 15
4. If female of child-bearing potential, a reliable method of contraception must be combined with a negative pregnancy test before entering the study (contraception must be used for 1 month after the last administration of 18F-FDG). If male, a barrier method of contraception should be used for up to 1 month after the last administration of 18F-FDG.
5. Able and willing to follow instructions and comply with the protocol.
6. Provide written informed consent prior to participation in the study.
7. Karnofsky Performance Scale Score 60-100.

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:

1. significant renal impairment (serum creatinine \> 200 µmol/L).
2. Coagulopathy (prothrombin time \[PT\] or activated partial thromboplastin time \[APTT\] \>1.5 times control).
3. Significant Thrombocytopenia (platelet count \< 75,000/mm3).
4. Granulocytopenia (absolute neutrophil count \< 1,000/mm3).
5. Blood glucose level Significant liver function impairment (total bilirubin \> 2.0 mg/dL; AST or ALT \> 3 times the upper limit of normal) or greater than 10.
6. Presence of a severe infection.
7. Having had surgery or radiotherapy within 10 days of the planned imaging study.
8. Nursing or pregnant females.
9. Age less than 15.

Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Cancer or Suspected Cancer

A Phase I/II, Phase III and Extended Phase III Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Cancer or Suspected Cancer

Carcinoma, Non-Small-Cell Lung

Positron Emission Tomography (PET) scan Imaging

Alexander McEwan, MB, MSc, MD

At this time, computed tomography (CT) is the standard tool used at this institution for the staging of non-small cell lung cancer (NSCLC). For most patients, treatment planning for NSCLC is performed with the patient breathing freely during CT scanning. However, recent research has demonstrated that, by holding one's breath briefly, the NSCLC tumor mass can be held motionless. As a result, the tissue to be treated is better pinpointed and the area treated is significantly decreased through breath-hold planning. This allows for a higher dose of radiation to be given to the cancer. PET scanning is a promising newer imaging modality which has shown to be useful in staging NSCLC. This study hypothesizes that breath-held PET scanning and breath held-CT scanning will allow for more stringent radiotherapy plans, minimizing normal tissue toxicity, as well as potentially increasing the dose deliverable to the primary tumor.

Concurrent chemotherapy and 3-dimensional conformal radiation therapy (3D-CRT), using computed-tomography (CT) simulation, is the current standard approach in the treatment of inoperable non-small-cell lung cancer (NSCLC). Despite such therapeutic benefit, local recurrence nonetheless remains a significant impediment to cure. Attempts to improve the accuracy of CT-scanning in radiotherapy treatment planning have been increasingly studied. One such approach is the attempted correlation of CT imaging temporally with the physiologic breathing cycle, a process known as gating. By imaging the tumor only when the tumor is immobilized, gating effectively eliminates the effect of motion, thus leading to typically smaller visible tumor masses and the loss of motion-induced distortions. Lung-tumor immobilization using self-gated breath-holding at extremes of inspiration has been validated clinically, and is associated with improved lung-outcome predictors and normal tissue complication probability overall. Several recent studies have demonstrated PET to be both highly sensitive and moderately to highly specific in the staging of NSCLC, and even more sensitive and specific than CT-scanning in the detection of mediastinal and distant metastases from NSCLC. The co-registration of CT and PET images enables even greater accuracy than either modality alone, while the functional imaging inherent in PET may better facilitate the distinction between benign and malignant structures. Overall, the superior tumor staging capability of PET (or PET-CT fusion) together with the improved dosimetry \& diminished normal-tissue toxicity associated with deep inspiration breath-hold (DIBH) is expected to confer considerable clinical advantage to the use of gated PET in the radiotherapeutic planning and treatment of NSCLC.

The first objective is to define the effect of respiratory-gating on PET-based radiotherapy planning in comparison to the free-breathing condition for patients with NSCLC. The endpoints here will be to quantify the variation of both PTV and normal-tissue complication probability (NTCP) for certain relevant organs (lung, esophagus, heart) via a direct analysis of calculated volumes.

The second objective is to identify the correlation between PET-based radiotherapy planning volumes and CT-based planning volumes for respiratory-gated patients with NSCLC. The endpoint for this objective will be to quantify the breath-held, PET-based PTVs and NTCPs in comparison to the breath-held, CT-based PTVs and NTCPs.

This study will consider patients with locally advanced non-small-cell cancer of the lung (NSCLC) who are eligible for radical (i.e. with curative intent) combined-modality therapy. Patients will be accrued from the new patient lung clinic at the Cross Cancer Institute. Following a complete clinical assessment comprising a thorough history and physical examination, a thorough analysis of all available imaging, a consideration of all available laboratory results and consideration of any ancillary test results (e.g. pulmonary function testing), a decision will be made whether or not to offer a patient radical therapy. In the case of any uncertainties, further tests, such as repeat CT scanning or diagnostic PET scanning may be arranged to define eligibility.

Eligibility Criteria:

* Histologically-proven, unresected lung cancer of the following histologic types: \*squamous cell carcinoma, \*adenocarcinoma, \*undifferentiated large cell carcinoma, \*non-small cell, not otherwise specified (NOS, diagnosis on cytology alone)
* AJC Stage I-III disease (if all detectable tumor can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes); patients with positive supraclavicular nodes (N3) are not eligible.
* Age \> 18 and Karnofsky performance status \> 70
* Measurable disease on the CT and PET images
* Patient must be deemed eligible for radical combined-modality therapy
* All patients must sign a study-specific informed consent form.

Ineligibility Criteria:

* M1 disease
* Karnofsky performance status \< 70 and age \< 18
* Patients who have undergone complete tumor resection
* Patients with post-resection intrathoracic tumor recurrence
* Evidence of small cell histology
* Prior or concurrent malignancy except non-melanomatous skin cancer (unless disease-free for at least 5 years)
* Prior radiotherapy to the thorax or neck
* Prior chemotherapy
* Patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure and uncontrolled arrhythmias
* Pregnant women; patients with childbearing potential must practice appropriate contraception.
* Inability to maintain a state of deep inspiratory breath-hold for a minimum length of time

Statistical Analysis: In a previous study comparing DIBH-gated CT-scanning to free-breathing CT-scanning performed at this institution, it was found that a sample size of 10 patients was appropriate to illustrate both a statistically significant reduction in PTV and a statistically significant reduction in V20 (the volume of lung treated to a dose of =20Gy). For the current study, given that the patient population is essentially the same as the last one, and the fact that PET and CT are comparable imaging modalities for NSCLC in terms of their sensitivity, a total sample size of 10 patients would be an appropriate number to assess the difference between breath-held PET and free-breathing PET (i.e. the first objective). This difference, in terms of both PTV and NTCP, will be assessed for statistical significance with a paired Student's t-test.

Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients Receiving a Treatment Planning Study of 3 Dimensional Conformal Radiation Therapy Guided by Breath Held CT and PET Imaging for Patients With Non-Small Cell Lung Cancer

A Phase II Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients Receiving a Treatment Planning Study of 3 Dimensional Conformal Radiation Therapy Guided by Breath Held CT and PET Imaging for Patients With Non-Small Cell Lung Cancer

Nutritional and Metabolic Diseases

Muscular Atrophy

Wasting Syndrome

Cachexia

Syndrome

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

This arm includes 150 treatment-naive lung cancer patients. Assessments include medical history, physical exams, lab tests, and imaging. Objective: investigate cancer cachexia, stress, and metabolic changes. Cachexia criteria: weight loss, reduced food intake, inflammation markers. Stress assessment: questionnaires, biomarkers. Metabolic changes measured by PET-CT scans analyzing FDG uptake in organs/lesions. Data will uncover the relationship between cancer cachexia, stress, and metabolic changes in treatment-naive lung cancer patients, leading to improved interventions/outcomes.

A subgroup of patients from Vienna will undergo an additional PET/CT scan after the first follow-up PET/CT, which takes place one month after stress reduction training. The stress reduction training involves performing a breathing technique.

Stress Reduction Training

Marcus Hacker, Prof., MD

Josef Yu, MD

Andreas Bergthaler, Prof.

Osama Sabri, Prof.

Roberto Sciagra, Prof.

Marcus Hacker, Prof.

Thomas Beyer, Prof.

Roberto Sciagrà, Prof.

This prospective observational study aims to investigate the relationship between cancer cachexia, stress levels, and metabolic changes in 150 lung cancer patients. Cancer cachexia, characterized by weight loss and muscle wasting, significantly impacts patient outcomes. Psychological stress is thought to contribute to cachexia development. Assessments will include medical history, physical examinations, laboratory tests, and imaging. Cancer cachexia will be diagnosed based on weight loss, reduced food intake, and inflammation markers. Psychological stress will be evaluated using questionnaires and biomarkers. Metabolic changes will be assessed using positron emission tomography-computed tomography (PET-CT) scans. The primary objective is to determine differences in metabolic activity between cachectic and non-cachectic patients. Secondary objectives include evaluating changes in brain activity and exploring the relationship between stress, inflammation, and metabolism.

Title: Investigation of the Relationship Between Cancer Cachexia, Stress, and Metabolic Changes in Lung Cancer Patients

Background: Cancer cachexia is a debilitating syndrome characterized by progressive weight loss, muscle wasting, and metabolic abnormalities. It significantly impacts patients' quality of life and survival outcomes. Psychological stress has been suggested as a potential contributor to cachexia development and progression. This study aims to investigate the association between cancer cachexia, stress levels, and metabolic changes in lung cancer patients.

Methods: This multicenter, prospective observational study will enroll 150 lung cancer patients. Eligible participants will undergo comprehensive assessments, including medical history review, physical examinations, laboratory tests, and diagnostic imaging. Cancer cachexia will be diagnosed based on established criteria, including weight loss, reduced food intake, and systemic inflammation markers. Psychological stress will be evaluated using validated questionnaires and stress biomarkers. Metabolic changes will be assessed through positron emission tomography-computed tomography (PET-CT) scans to measure fluorodeoxyglucose (FDG) uptake in organs and lesions.

Primary Objectives: The primary objective is to determine differences in FDG uptake between cachectic and non-cachectic lung cancer patients in various organs and lesions. Secondary objectives include evaluating changes in amygdalar FDG uptake after stress intervention and exploring the relationship between stress, inflammatory markers, and metabolic changes.

Statistical Analysis: Student's t-test will be used to compare FDG uptake between groups, and descriptive statistics will be calculated for each brain region. Sample size calculations indicate a need for approximately 30 subjects per group to detect significant differences. Data will be analyzed using appropriate statistical software.

Ethical Considerations: Informed consent will be obtained from all participants, and the study will adhere to the principles outlined in the Declaration of Helsinki and Good Clinical Practice guidelines. The study protocol has been submitted to the Ethics Committee and regulatory authorities for approval.

Conclusion: This study aims to provide insights into the relationship between cancer cachexia, stress, and metabolic changes in lung cancer patients. By investigating FDG uptake in different organs and lesions, as well as amygdalar FDG uptake before and after stress intervention, this research may contribute to the development of targeted interventions for cachexia management and improve patient outcomes.

The overall model of this study involves enrolling a total of 150 patients from three different sites. These patients will undergo baseline PET/CT imaging to assess their metabolic changes, as well as provide clinical information through medical history review and physical examinations. Additionally, blood samples will be collected for laboratory tests, and patients will complete questionnaires to evaluate psychological stress levels. This comprehensive approach aims to gather a range of data including imaging, clinical information, blood biomarkers, and psychological assessments to investigate the relationship between cancer cachexia, stress, and metabolic changes in lung cancer patients.

Predicting Lung Cancer-Associated Cachexia With PET Imaging

The Role of 18F-FDG PET/CT in the Early Prediction of Cachexia in Lung Cancer Patients

Measurement of fluorodeoxyglucose (FDG) uptake in various organs and lesions to characterize the metabolic differences between cachectic and non-cachectic lung cancer patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Soft Tissue Sarcoma	NCT00123786	Sarcoma	Positron Emissi...	15 Years -	AHS Cancer Control Alberta
Peroperative Assessment of Tumour Resection Margins Using High-resolution 18F-FDG-PET/CT in Pancreatic Adenocarcinoma	NCT05023291	Fluorodeoxygluc...	Positron Emissi...	18 Years -	University Hospital, Ghent
Study of Fluorodeoxyglucose (FluGlucoScan) in Patients With Breast Cancer: Correlation With Histologic Findings of Sentinel Node Biopsies and Axillary Dissection	NCT00123799	Breast Neoplasm...	Positron Emissi...	18 Years -	AHS Cancer Control Alberta
FDG-PET-Stratified R-DICEP and R-Beam/ASCT For Diffuse Large B-Cell Lymphoma	NCT00530179	Diffuse Large B...	Autologous Bloo... R-CHOP	18 Years - 65 Years	AHS Cancer Control Alberta
Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.	NCT03470857	Neoplasms Antioxidants Oxidative Stres... Lipid Peroxidat... Inflammation Lysosome Altera...	Patients	18 Years -	Nicolaus Copernicus University
Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Soft Tissue Sarcoma	NCT00123786	Sarcoma	Positron Emissi...	15 Years -	AHS Cancer Control Alberta
Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Cancer or Suspected Cancer	NCT00123760	Brain Neoplasms Lung Neoplasms Thyroid Neoplas... Colorectal Neop... Lymphoma	Positron Emissi...	15 Years -	AHS Cancer Control Alberta
Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients Receiving a Treatment Planning Study of 3 Dimensional Conformal Radiation Therapy Guided by Breath Held CT and PET Imaging for Patients With Non-Small Cell Lung Cancer	NCT00123747	Lung Neoplasms	Positron Emissi...	18 Years -	AHS Cancer Control Alberta
Predicting Lung Cancer-Associated Cachexia With PET Imaging	NCT05912465	Cachexia Lung Neoplasm	Stress Reductio...	18 Years -	Medical University of Vienna
Study of F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Cancers of Low Incidence	NCT00123773	Sarcoma Multiple Myelom... Testicular Neop... Ovarian Neoplas... Kidney Neoplasm...	Positron Emissi...	15 Years -	AHS Cancer Control Alberta
Hepatosplenic CANdidiasis : PETscan and Immune Response Analysis	NCT01916057	Invasive Fungal... Chronic Dissemi... Hematological M... Hematopoietic S... Neutropenia	18F-FDG PET Sca...	18 Years -	Assistance Publique - Hôpitaux de Paris

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