Symptoms and General Pathology

All Conditions

Neoplasms

Mouth and Tooth Diseases

Rare Diseases

Hypoxia

Tongue Neoplasms

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Tongue Diseases

Tongue Cancer

Oral Cancer

All Drugs and Chemicals

Fluoroazomycin arabinoside

Radiopharmaceuticals

(18)F-Fluoroazomycin arabinoside (FAZA) will be administered via intravenous injection at a dose of 5.2 MBq/kg with a minimum dose of 200 Megabecquerel (MBq) (5.4 Millicurie (mCi)) and a maximum dose of 600 MBq (16.2 mCi) prior to positron emission tomography (PET) imaging. A single dose of oral pimonidazole capsules at a dose of 0.5 g/m2, will be taken by participants 16-20 hours prior to tumor resection surgery.

(18)F-Fluoroazomycin arabinoside

Pimonidazole

Ian Poon, MD, FRCPC

This is a pilot study in the form of a prospective Phase II, single centre, single arm hypoxia study of oral tongue cancer with FAZA-PET imaging and pimonidazole targeted IHC of surgical specimens.

In head and neck cancer, areas of tumours with low oxygen supply (called tumour hypoxia) harbour cells that are resistant to radiation and are prone to metastasize. Modern radiotherapy techniques are precise enough to deliver radiation to these small areas and could be used to target these areas to receive higher doses of radiation than the rest of the tumour to overcome resistance. Hypoxia can be "seen" in the body using special imaging such as \[F-18\]-FAZA-PET (\[F-18\]-Fluoroazomycin arabinoside positron emission tomography) but it has not been tested as a method for creating radiation treatment targets. As part of regular pathology tumour tissue is sliced extremely thinly (\<1/100th of a millimeter) and stained so that individual cells can be seen under a microscope. Immunohistochemistry (IHC) is a special type of "stain" that can specifically highlight hypoxic areas. This method is considered the most accurate way to inspect for the presence of hypoxia. There is not a specific staining target for hypoxia ordinarily, but when patients ingest a substance called pimonidazole hydrochloride (HCl) it builds up specifically in hypoxic areas and can be targeted for IHC staining. In this study participants with oral tongue cancer will have a \[F-18\]-FAZA-PET scan and take a single dose of oral pimonidazole-HCl before having surgery to remove their cancer. The whole tumour will be used to create microscope slides using very thin slices of the tumour. The slices will be stained using IHC to show where the pimonidazole has built up and digital scans of the slides will be made. The hypoxia seen on the FAZA-PET scan will be "matched" with hypoxia on the electronic slides to see if the FAZA truly shows where hypoxia is in tumours and if it could be used as a way to plan radiation treatments to deliver more radiation to just those areas.

Correlation of FAZA PET Hypoxia Imaging To 3D Histology in Oral Tongue Cancer

Defining a Personalized Hypoxic Radiation Target Through Correlation of Functional F18-FAZA PET Imaging to Pimonidazole-stained 3D Whole-mounted Histological Specimen

The degree to which hypoxic signal measured by FAZA-PET imaging is correlated with true cellular hypoxia confirmed by immunohistochemical staining of pimonidazole using a 3D whole-mount approach

A reference standard hypoxic radiation target will be defined through the correlation of functional F18-FAZA PET imaging to a pimonidazole-stained 3D whole mounted histological specimen.

The quality of registration will be assessed through measuring registration error of various automatic and semi-automatic co-registration techniques

Potential relationships between textural features of MRI, PET-CT, and immunohistochemistry will be evaluated.

Sunnybrook Research Institute

University of Toronto

Sunnybrook Health Sciences Centre

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Signs and Symptoms, Respiratory

Patients randomized to this group will perform a wattmax test immediately followed by 4 intervals of high and low intensity based on percentage of wattmax. Immediately after the exercise bout is finished patients will receive one dose of pimonidazole hydrochloride (500 mg per m2 body surface) in order to quantify tumor hypoxia by pathological analyses after removal of the prostate by radical prostatectomy the following day.

Patients randomized to the control group will not be doing any exercise, but will after approximately 35 min from baseline blood sampling receive one dose of pimonidazole hydrochloride (500 mg per m2 bodysurface) in order to quantify tumor hypoxia by pathological analyses after removal of the prostate by radical prostatectomy the following day.

Patients randomized to the HIIT bout will perform one single supervised High Intensity Interval Training bout consisting firstly of a wattmax test on a stationary bike, in order to set the training intensity. This is followed by 10 minutes at low intensity at approximately 30% of wattmax. Subsequently patients will perform 16 min with 4 cycles with High and Low intensity. HI intervals consisting of 1 min with 100% of wattmax followed by 3 min recovery with the intensity load of 30% of wattmax.

High Intensity Interval Training bout

Sissal S Djurhuus, MD

Background and purpose: The purpose of this study is to investigate the effect of one acute exercise bout on tumor hypoxia in patients with localized prostate cancer undergoing radical prostatectomy.

The primary hypothesis is that exercise reduces tumor hypoxia and that the reduction is greater in patients performing one acute high intensity exercise bout compared to no training controls.

The investigators have not been able to identify any prior or current randomized trials investigating exercise and tumor hypoxia, and believe that such research is warranted and would be of great importance. Moreover there is a need for studies including biological measurements to allow a full assessment of the effect of exercise on diverse biomarkers and mechanistic pathways, which may influence cancer survival.

Subjects: Patients with histologically verified prostate adenocarcinoma scheduled for radical prostatectomy at Urologic Department, Rigshospitalet, Copenhagen, Denmark.

Methods: In this randomized controlled pilot study 30 patients with localized prostate cancer undergoing radical prostatectomy will be included and randomized 2:1 to either one single acute High Intensity Interval Training bout or usual care and no training the day prior to radical prostatectomy.

All patients will undergo assessment at inclusion (baseline) and the day prior to surgery.

Assessment includes: anthropometrics; blood pressure; resting hearth rate; hip and waist circumference, ECG, quality of life by self-report questionnaires; fasting blood sample measuring PSA (prostate specific antigen), cholesterol, triglycerides, insulin, c-peptide, HbA1c, glucose and inflammatory markers.

All patients will receive one dose of pimonidazole hydrochloride (500 mg per m2 body surface) in order to quantify tumor hypoxia by pathological analyses after removal of the prostate.

Biological tissue from tumor (primary prostate biopsies) will also be retrieved from the respective local pathological departments and from the perioperative prostate specimen and sent to protocol analyses.

The purpose of this study is to investigate the effect of one acute exercise bout on tumor hypoxia in patients with localized prostate cancer randomized to one single acute I) High Intensity Interval Training bout compared to (II) usual care and no training prior to radical prostatectomy.

In addition to this the aim is to investigate the effect of one exercise bout on tumor vessel morphology and to investigate the effect of one acute exercise bout on intratumoral immune cell infiltration and to investigate the modulation of tumor-metabolism, -biology and signaling in patients randomized to either one acute High Intensity Interval Training bout compared to usual care and no training, the day prior to surgery.

Moreover this study will explore the acute response in immune cells, hormones and cytokines in blood samples taken before, during and after a single exercise session, and will collect physiological (metabolic profile and metabolic inflammatory markers) and psycho-social (e.g. fatigue, emotional well-being, anxiety) information regarding patients randomized to either one acute High Intensity Interval Training bout compared to usual care and no training, the day prior to surgery.

The Effect of Exercise on Tumor Hypoxia in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy.

The Effect of Exercise on Tumor Hypoxia in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy - a Randomized Controlled Pilot Study

Quantification of tumor hypoxia will be assessed using pimonidazole staining

Intratumoral immune cell infiltration will be quantified using histological analyses

Tumor vessel morphology will be evaluated using histological analyses

Tumor samples will undergo proteomic analyses in order to uncover potential upregulated biomarkers

Changes in immune cells during an acute exercise bout will be measured in blood samples using flowcytometry

Concentration of epinephrine will be measured in blood samples by radioimmunoassay analyses.

Concentration of nor-epinephrine will be measured in blood samples by radioimmunoassay analyses.

Concentration of various interleukines will be measured in blood samples by measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.

Concentrations of TNFa will be measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.

Concentrations of IFNγ will be measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.

Concentration of CRP will be measured in fasting blood sample by standard laboratory methods.

Concentrations of total cholesterol will be measured in fasting blood samples by standard laboratory methods.

Concentrations of LDL- cholesterol will be measured in fasting blood samples by standard laboratory methods.

Concentrations of HDL- cholesterol will be measured in fasting blood samples by standard laboratory methods.

Concentrations of triglycerides will be measured in fasting blood samples by standard laboratory methods.

Concentrations of HbA1C will be measured in fasting blood samples by standard laboratory methods.

Concentrations of insulin will be measured in fasting blood samples by standard laboratory methods.

Concentrations of glucose will be measured in fasting blood samples by standard laboratory methods.

The participants in the HIIT group will undergo a maximal graded exercise test on a bicycle ergometer for evaluation of cardiovascular function and determination of the maximum watt (wattmax). The test starts with a 3 min warm up at 70 watt (the watts may have to be adjusted to the individual fitness level). Warm up is immediately followed by a 20 watt increase every 1 min until exhaustion. The maximum watt will be calculated.

Rigshospitalet, Denmark

Principal investigator

Starting two weeks prior to the initiation of radiotherapy serial, 7x blood samples will be taken every two days, excluding the weekend (for example, if starting on a Monday: Monday-Wednesday-Friday-Monday-Wednesday-Friday and Monday), but also on the day of the first radiotherapy treatment, to define the serial high-sensitivity C-reactive protein (hs-CRP) test, LDH and white cell differential count (leucocytes: neutrophils, basophils, eosinophils, lymphocytes, monocytes). Data from the assays will be assembled in a spreadsheet and analyzed for levels and cyclical fluctuations to determine each patient's idiosyncratic immune cycle's periodicity and then each patient's time-position of initiation of treatment and response to therapy.

SBRT-PATHY will be administered to this arm at an estimated "less favorable time-Position in immune cycle".

Starting two weeks prior to the initiation of radiotherapy serial, 7x blood samples will be taken every two days, excluding the weekend (for example, if starting on a Monday: Monday-Wednesday-Friday-Monday-Wednesday-Friday and Monday), but also on the day of the first radiotherapy treatment, to define the serial high-sensitivity C-reactive protein (hs-CRP) test, LDH and white cell differential count (leucocytes: neutrophils, basophils, eosinophils, lymphocytes, monocytes). Data from the assays will be assembled in a spreadsheet and analyzed for levels and cyclical fluctuations to determine each patient's idiosyncratic immune cycle's periodicity and then each patient's time-position of initiation of treatment and response to therapy.

SBRT-PATHY will be administered to this arm at an estimated "most favorable time-position in immune cycle".

Novel stereotactic high-dose partial irradiation of the hypoxic segment of bulky tumors.

SBRT-PATHY (SBRT-based PArtial Tumor irradiation targeting HYpoxic segment)

Slavisa Tubin, M.D.

This study uses an unconventional radiotherapy schedule developed at our institute, consisting of a short course high-dose partial irradiation targeting exclusively the hypoxic segment of a bulky tumors, which in our preliminary study has shown to be capable of inducing abscopal and bystander effects. This approach is delivered by using a stereotactic radiotherapy technique so as to spare nearby organs at risk including the peritumoral immune microenvironment from irradiation as much as possible. Our approach consists of a single or up to 3 radiotherapy doses of at least 10 Gy per fraction prescribed to the 70% isodose line encompassing the hypoxic target volume. Radiotherapy will be administered at the precise timing determined specifically for each patient based on the serially mapped homeostatic immune fluctuations by monitoring the blood levels of the cytokines and inflammatory markers over the 2 weeks prior to irradiation. This is done in order to synchronize the radiation treatment with the favorable, most active anti-tumor immune system phase, so as to stimulate and increase anti-tumor immune system activity.

This is a monocentric, prospective, two-arm, phase I proof of principle study in which the investigator will enroll subjects with oligometastatic and/or locally advanced (N+) cancers with at least one "bulky" lesion (maximum diameter of at least 6 cm or greater). Patients with life expectancy of at least 3 months, who are ineligible for systemic therapy or experience disease progression with systemic therapies will be included. Radiotherapy will be administered to arm 1 at an estimated "less favorable time-position in immune cycle", while the second arm will have it administered at the estimated "most favorable time-position in immune cycle".

The primary endpoint will be the response rate of the non-targeted effects both bystander (local, at the level of the partially treated bulky tumor) and abscopal (distant, at the non-treated metastatic sites), defined as a tumor regression of at least 30%. Secondary endpoints will be safety, survival and analysis of the best timing for the administration of radiotherapy.

The purpose of this study is to evaluate the effectiveness of our new method for high dose partial irradiation of the hypoxic tumor segment of bulky masses in terms of the intentional induction of the non-targeted effects of radiotherapy in patients with metastatic or locally advanced (N+) malignancies who are ineligible for, or currently in progression under systemic therapies. By mapping the homeostatic immune fluctuations serially, and by monitoring the blood levels of the cytokines and inflammatory markers over the 2 weeks prior to irradiation, radiotherapy will be administered at the precise, optimal timing in order to stimulate and to increase anti-tumor immune system activity.

Primary endpoint: bystander (local) and abscopal (distant, metastatic or lymph nodal sites) response rates.

Secondary endpoints: overall safety and tolerability profile of our new radiotherapy method, progression-free survival rates at local and distant sites, as well as overall survival rates, efficacy of this regimen in palliating symptoms, neoadjuvant potential of this novel radiotherapy for unresectable/borderline resectable bulky lesions, optimal timing for radiotherapy to be administered based on the fluctuating/oscillating suppressed anti-tumor immune response.

This monocentric, two-arm prospective phase I proof of principle trial will enroll 26 patients from a single institution: KABEG Klinikum Klagenfurt am Woerthersee, Austria.

During the visit, and after clinical examination, patients will be eligible if they satisfy the inclusion criteria for participation in this pilot study on the use of the novel stereotactic radiotherapy technique which will consist of partial irradiation of exclusively hypoxic segments of their bulky tumors, with 1-3 high dose fractions of radiotherapy based on the tumor's site, volume and its relationship with nearby organs. The irradiation will take place within 3 weeks of clinical examination. After the treatment, the patient will be regularly followed for the evaluation of all endpoints. If any severe toxicity (grade ≥3 per CTCAE v 4.3 criteria) occurs in the first 7 evaluable patients, the trial will stop. Safety reviews will continue on an ongoing basis, provided that severe toxicities do not occur in more than 15% of patients. In the case of eventual disease progression during the follow-up, the patients will be offered additional local (radiotherapy) or systemic (chemotherapy, immunotherapy, hormonal therapy) treatment if indicated by current NCCN (National Comprehensive Cancer Network) treatment recommendations and guidelines.

Routine surveillance computerized axial tomography (CT) imaging of the whole body will be performed beginning at 1 month (+/- 3 days) after treatment to allow for endpoint assessment - or before in any case of clinical suspicion of disease progression. Routine CT imaging surveillance will continue per standard of care. Patients will also be followed clinically with physical and laboratory examinations as indicated.

Tumor assessments will be completed on the CRF using RECIST v1.1. criteria. Radiographic and clinical evaluations will be conducted with the same schedule. The investigator will assess anti-tumor activity based on radiological assessments and clinical evaluations of patients using RECIST v1.1 at baseline, 1 and 2 months post-treatment, and every 3 months thereafter until confirmed disease progression per RECIST v1.1, regardless of the discontinuation of study treatment or the initiation of subsequent anti-cancer therapy. Radiological tumor assessments will also be conducted whenever disease progression is suspected (e.g. symptomatic deterioration or physical examination findings suggestive of mucosal recurrence).

Starting two weeks prior to the initiation of radiotherapy serial, 7x blood samples will be taken every two days, excluding the weekend (for example, if starting on a Monday: Monday-Wednesday-Friday-Monday-Wednesday-Friday and Monday), but also on the day of the first radiotherapy treatment, to define the serial high-sensitivity C-reactive protein (hs-CRP) test, LDH and white cell differential count (leucocytes: neutrophils, basophils, eosinophils, lymphocytes, monocytes).

Data from the assays will be assembled in a spreadsheet and analyzed for levels and cyclical fluctuations to determine each patient's idiosyncratic immune cycle's periodicity and then each patient's time-position of initiation of treatment and response to therapy. Radiotherapy will be administered to the arm 1 (13 patients) at an estimated "less favorable time-position", while it will be administered to the arm 2 (13 patients) at an estimated "most favorable time-position in immune cycle".

SBRT-based PArtial Tumor Irradiation of HYpoxic Segment

CLINICAL EXPLORATION OF THE NON-TARGETED EFFECTS OF STEREOTACTIC RADIOTHERAPY IN PATIENTS WITH UNRESECTABLE BULKY TUMORS TREATED BY PARTIAL HIGH-DOSE IRRADIATION OF HYPOXIC TUMOR SEGMENT: PHASE I PROOF OF PRINCIPLE TRIAL.

Rates of significant (30% or more) tumor regression at the level of both the partially treated bulky tumors (bystander effects) and unirradiated oligometastases and/or regional lymph nodes (abscopal effect).

The length of time from the start of treatment for a cancer, that patients diagnosed with the disease are still alive.

The length of time during and after the treatment of a cancer, that a patient lives without disease-progression.

Health outcome directly reported by the patient who experienced the cancer-related symptoms.

Clinician reported radiation related toxicity as a standardized system to quantify or grade the severity of adverse events that occur during or after radiation treatment.

The assessments of tumor response to radiotherapy will be performed using RECIST v1.1. criteria at 1 and 2 months post-treatment, and every 3 months thereafter using CT, MRI or PET-CT to assess the neoadjuvant potential of SBRT-PATHY expressed as significant (\>30% tumor-volume reduction in respect to initial tumor volume) downsizing of unresectable bulky tumors into resectable tumors.

Determination of the optimal timing for radiotherapy treatment to be administered by correlating the clinical outcomes with the phase or position on the immune cycle at which the treatment occurred.

Klinikum Klagenfurt am Wörthersee

Vice-Chairman of the Radiation Oncology Institute, Klinikum Klagenfurt am Wörthersee

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Hypoglycemic Agents

Metformin

Radiotherapy as per standard of care without metformin, no additional biomarkers/imaging will be performed

Radiotherapy as per standard of care without metformin, with additional biomarkers/imaging

Radiotherapy as per standard of care with metformin, with additional biomarkers/imaging

Metformin 500 mg given 14 days before start until the end of radiation therapy. Once daily during the first 7 days, afterwards twice daily until the end of treatment.

No metformin

Jan van Meerbeeck, PhD, MD

Study the effect of metformin when added to definitive locoregional radiotherapy on locoregional control and relapse rate in stage III non-small cell lung cancer patients receiving sequential chemoradiotherapy. Try to identify subsets of patients who derive maximum benefit of adding metformin to radiotherapy using innovative biomarkers.

The administration of oral metformin during radiotherapy is thought to decrease the hypoxic fraction of tumour cells, improving radiosensitivity and promoting apoptosis, resulting in better outcome. This hypothesis will be evaluated in a trial with randomized design. All patients willing to participate will receive definitive radiotherapy, either in combination with metformin (arm C) or without metformin (arm B). Patients who refuse to participate in the randomized part can be included in the observational arm of the study (arm A). In addition, the validated biomarker of tumour hypoxia (18F-HX4 PET/CT scintigraphy (18F-flortanidazole positron emission computed tomography) and biomarkers of resistance, apoptosis and glucose metabolism will be evaluated for their potential predictive value.

Prospective multicentre trial, consisting of an observational lead-in phase and a randomized phase II using a 1:1 ratio. All patients willing to participate will receive definitive radiotherapy either in combination with metformin (arm C) or without metformin (arm B).

The Addition of Metformin to Definitive Radiotherapy in Patients With Stage III NSCLC

Randomized Phase II Trial of Definitive Radiotherapy With or Without metFORMin in Patients With Inoperable Stage III Non-small Cell Lung Cancer

Stand Up To Cancer

ethisch.comite@uza.be

Head of Department Thoracic Oncology + Principal Investigator (Prof. Dr. Jan van Meerbeeck)

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Disease Progression

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Oculocerebral Syndrome With Hypopigmentation

Antineoplastic Agents

Hematinics

Chlorotrianisene

Liver Extracts

Patients with primary hepatic malignancy who underwent \[18F\] FMISO PET Scan following transarterial chemoembolization (TACE) procedure

\[18F\] Fluromisonidazole, 1 h-(3-\[18F\]-fluro-2hydroxyl-propy10-2-nitro-imidazaole is an investigational positron emission tomography (PET) radiopharmaceutical for injection and used to visualize hypoxia imaging agent. Each patient will receive up to 10 mCi of \[18F\] FMISO PET imaging post TACE procedure.

[18F] FMISO

Elliot B Levy, M.D.

Background:

- Treatment for liver cancer can include surgery, transplant, and chemotherapy. It can also include other minimally invasive tumor treatments such as transarterial chemoembolization (TACE). TACE treatment for liver cancer helps control the cancer but is not considered a cure. Researchers want to learn more about the effects of TACE on liver tumors and surrounding tissue. To do this, they will use a positive emission test (PET) and a radioactive tracer called \[18F\] FMISO.

Objectives:

- To see if \[18F\] FMISO is useful for evaluating what happens to liver tumors and surrounding tissue after TACE.

Eligibility:

- People age 18 and older with liver cancer who have been approved to have TACE.

Design:

* Participants will meet with a study researcher to see if they can take part in the study.
* Participants will have TACE under a separate NCI protocol or at a hospital other than the NIH Clinical Center.
* Before and after TACE, participants will have a CT and MRI of the abdomen. For these scans, they will lie in a machine that takes pictures of their body. They will also have blood tests and a physical exam.
* The \[18F\] FMISO imaging study will be performed at NIH only.
* Participants will have an intravenous catheter placed in their arm (if they do not have one). The \[18F\] FMISO tracer will be injected.
* Participants will have PET-CT scans. Each scan will take about 30 minutes.
* Some participants will also have \[18F\] FMISO and PET-CT scans before TACE.
* As part of standard care for TACE, participants will have CT and MRI scans at regular intervals. This will evaluate tumor response.

Background

* TACE is the standard therapy for inoperable primary liver cancers or tumor control prior to transplantation. The mechanisms for TACE s failure remains poorly understood.
* Although acute hypoxia and significant tumor necrosis occurs following TACE, the tumor adaptive response and localization for such have not been well characterized.
* Imaging tools using a hypoxia-specific tracer \[(18)F\] FMISO may help identify the pattern and distribution of acute post-TACE tumor hypoxia relative to demonstrated tumor progression.
* The primary hypothesis of this study states that tumor progression post-TACE arises from changes in tumor phenotype induced by treatment-related hypoxia superimposed on the dynamic process of underlying tumor hypoxia.

Objectives

-To determine the feasibility of hypoxic tumor identification despite relatively high liver background signal, and describe patterns of tumor hypoxia in the immediate post-TACE treatment period using PET imaging \[(18)F\] MISO uptake registered with cross-sectional imaging.

Eligibility

* Patients greater than or equal to 18 years with inoperable primary hepatic malignancy or hepatic-dominant metastatic-disease and be otherwise eligible to receive TACE treatment. Patients with hepatocellular carcinoma should have intermediate stage disease according to the BCLC staging system (Stage A4 or B).
* Patients must not have had chemotherapy- or radiation therapy to liver for at least 2 weeks prior to starting study treatments.
* Patients must not have an acute, critical illness.
* Patients must not be pregnant
* Able to understand and be willing to sign a written informed consent

Design

* Fifteen patients with primary or metastatic liver malignancy will be enrolled into this pilot, non-randomized, open study of the feasibility of using (18)F-fluoromisonidazole PET scanning to determine hypoxic tumor identification and localization, and to identify the pattern and distribution of acute post-TACE tumor hypoxia relative to demonstrated tumor progression.
* Twenty-four to seventy-two hours after standard of care TACE, patients will undergo

PET scanning using 0.1mCi/kg (maximum 10mCi) of (18)F-fluoromisonidazole \[(18)F\] MISO).

Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization

A Pilot Study of an Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization

A single dose of study imaging agent \[18F\] FMISO was administered following the TACE procedure. PET Scan imaging was then performed to evaluate if hypoxic tumor identification were observable following administration of study imaging agent. Power and significance calculations are not applicable to this small sample feasibility study.

National Institutes of Health Clinical Center (CC)

Patients with primary hepatic malignancy are undergo \[18F\] FMISO PET Scan following transarterial chemoembolization (TACE) procedure.

[18F] FMISO PET Scan

Patients with primary hepatic malignancy who underwent \[18F\] FMISO PET Scan following transarterial chemoembolization (TACE) procedure

\[18F\] FMISO: \[18F\] Fluromisonidazole, 1 h-(3-\[18F\]-fluro-2hydroxyl-propy10-2-nitro-imidazaole is an investigational positron emission tomography (PET) radiopharmaceutical for injection and used to visualize hypoxia imaging agent. Each patient will receive up to 10 mCi of \[18F\] FMISO PET imaging post TACE procedure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Correlation of FAZA PET Hypoxia Imaging To 3D Histology in Oral Tongue Cancer	NCT03181035	Tongue Cancer	(18)F-Fluoroazo... Pimonidazole	18 Years -	Sunnybrook Health Sciences Centre
The Effect of Exercise on Tumor Hypoxia in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy.	NCT03675529	Prostate Cancer	High Intensity ...	18 Years -	Rigshospitalet, Denmark
The Effect of Exercise on Tumor Hypoxia in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy.	NCT03675529	Prostate Cancer	High Intensity ...	18 Years -	Rigshospitalet, Denmark
SBRT-based PArtial Tumor Irradiation of HYpoxic Segment	NCT04168320	Bystander Effec... Abscopal Effect Unresectable Ma... Bulky Tumors	SBRT-PATHY (SBR...	18 Years - 100 Years	Klinikum Klagenfurt am Wörthersee
The Addition of Metformin to Definitive Radiotherapy in Patients With Stage III NSCLC	NCT04170959	Carcinoma, Non-...	Metformin No metformin	18 Years -	University Hospital, Antwerp
Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization	NCT02471313	Liver Cancer Liver Neoplasm Hepatocellular ... HCC	[18F] FMISO	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
SBRT-based PArtial Tumor Irradiation of HYpoxic Segment	NCT04168320	Bystander Effec... Abscopal Effect Unresectable Ma... Bulky Tumors	SBRT-PATHY (SBR...	18 Years - 100 Years	Klinikum Klagenfurt am Wörthersee
Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization	NCT02471313	Liver Cancer Liver Neoplasm Hepatocellular ... HCC	[18F] FMISO	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for tumor hypoxia