Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Carcinoma, Ductal

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Fluorodeoxyglucose F18

Pierre VERA, PhD

Use of positron emission tomography (PET) in determination of functional tumour volume can provide usable information for radiotherapy to define the irradiated volume.

To determine the best tumour volume measure method, the investigators have chosen as model the breast cancer which allows us to study a stationary or moving organ by the patient position and belonging to a primary surgery.

The used methodology is based on lesion volume measure in preoperative time, obtained with PET, and on the measure of specimen volume by the anatomic laboratory after surgery.

This study's main objective is to compare this two measure of tumour size and secondarily to compare TEP with or without respiratory gating.

The PET-scan is achieved with FDG, under his French permission marketing, and acquire in 3 times:

A whole body acquisition in supine position, follow by a centered tumour acquisition with respiratory gating, then an acquisition in prone position to immobilise the lesion.

This study is monocentric and descriptive. It provides to include 30 patients in 1 year.

The use of positron emission tomography (PET) in determination of functional tumour volume may pose two major problems especially for the exact delineation of tumour contours:

* Respiratory movements, when the tumour is thoracic, may induce an overestimation
* The PET's low spatial resolution, linked to the emission of photons

The usual method to define tumour contours result of three types of delineation usually used: the visual contouring, the segmentation based on an activity threshold fixed, and the segmentation with adaptive thresholding.

Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer

Centre Henri Becquerel

heads of nuclear medecine department

Digestive System Diseases

Rare Diseases

Esophageal Neoplasms

Esophageal Cancer

THILLAYS Marc, RCA

THILLAYS Marc, RT

GOUEL Pierrick, RT

BENYOUCEF Ahmed, MD

VERA Pierre, MD phD

MICHEL Pierre, MD phD

The poor prognosis in the early-stage of oesophageal carcinoma cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments.

FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose consumption. Then, this exam is used for pathology staging, target volume definition for RT, and treatment efficiency few months after CRT. Our assumption is that an FDG-PET exam during the course of CRT might be predictive of the treatment efficiency few months later.

In this study, we propose to perform 4 FDG-PET: first "PET1" before chemo-radiotherapy, second "PET2" during the chemo-radiotherapy (see RTEP1), third and fourth "PET3" "PET4" 3month and 12 month after the end of radiotherapy.

We will investigate the performances of FDG-PET performed during CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, we would be able to optimize the planning treatment during the course of the therapy.

Predictive Value of Pet Scan With Fdg Performed During Irradiation in Patients Treated for Oesaphagus Carcinoma

Predictive Value of FDG-TEP During Exclusive Chemo-Radiotherapy (CRT) in Patients With Oesophageal Carcinoma Cancer on the One-Year Survival (RTEP3)

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Bronchial Neoplasms

Carcinoma, Bronchogenic

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Bronchial Diseases

GUERNOU Mohamed, MD

Study of the modification of the fixation(binding) of Fluoro-2-deoxy-D-glucose (FDG), fluoro-misonidazole (FMISO) and 3'deoxy-3-fluoro-thymidine deoxy-3-fluoro-thymidine (FLT) measured in tomography by broadcast(emission,issue) of positrons (PET) at patients before and in the course of exclusive radiotherapy or concomitant radiochemotherapy for primitive bronchial cancer.

This protocle allows to study the simultaneous variations of the metabolism, the hypoxie and the cellular proliferation by PET SCAN at 5 patients reached(affected) by a primitive bronchial cancer in the course of exclusive radiotherapy for primitive bronchial cancer not small cell lung.

The investigators are also going to study several scenarii of optimization of the radiotherapy according to the variations of the tumoral metabolism, the hypoxie and the cellular proliferation measured in the course of radiotherapy (theoretical study on console using the scanner and the various examinations).

Study of the Fixation of Various Vectors in PET/CT in Patients With a With Lung Cancer Before and During of CRT or RT

Study of the Modification of the Fixation of FDG, F-Miso and FLT Measured in PET/CT at Patients Before and in the Course of Exclusive Radiotherapy or Concomitant Radiochemotherapy for Primitive Bronchial Cancer

Mohamed GUERNOU MD

Patients treated with curative and exclusive radiotherapy (60 Gy minimum), with possibly prior chemotherapy

Patient treated with concomitant chemotherapy and radiotherapy (60 Gy minimum), with possibly prior chemotherapy chemotherapy Treatment

Positron Emission Tomography

Bernard DUBRAY, phD

The poor prognosis in the early-stage of lung cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments.

FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose consumption. Then, this exam is used for pathology staging, target volume definition for RT, and treatment efficiency few months after RT or CRT. Our assumption is that an FDG-PET exam during the course of the RT or CRT might be predictive of the treatment efficiency few months later.

In this study, the investigators propose to perform 4 FDG-PET: first "PET1" before radiotherapy, second "PET2" during the radiotherapy (see RTEP1), third and fourth "PET3" "PET4" 3month and 12 month after the therapy.

The investigators will investigate the performances of FDG-PET performed during the RT or CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, the investigators would be able to optimize the planning treatment during the course of the therapy.

Predictive Value of FDG-TEP During Radiotherapy or Chemo-radiotherapy in Patients With NCSC on the One-year Survival

Predictive Value of FDG-TEP During Radiotherapy (RT) or Chemo-radiotherapy (CRT) in Patients With Non Small Cell Lung Cancer on the One-year Survival

Measure of FDG-TEP uptake variation (SUV max) to assess predictive value of FDG-TEP during radiotherapy

Symptoms and General Pathology

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Hypoxia

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Squamous Cell

Recently, a polymerase chain reaction (PCR) -based hypoxia classifier gene signature was published that can be easily applied. Using this classifier, patients will be divided in hypoxic or non-hypoxic subgroups.

These subgroups will be correlated to locoregional control. The hypoxic signature will also be related to parameters on DCE-MRI, DWI and FDG-PET.

A polymerase chain reaction -based hypoxia classifier

As part of the standard staging procedure all patients will undergo an MRI of the neck. We will however also take DWI and DCE images at this time point. Parameters of these images will be later on correlated with pathology.

Functional imaging before treatment.

At 3 levels of the tumour, chosen by the radiologist on the functional imaging modalities, 4µm thick slices will me taken. On each level an immunohistochemical staining will be carried out (GLUT-1, CA-IX, HIF-1alpha, VEGF, KI 67). The result of this staining will be correlated with parameters derived from the functional imaging modalities.

Immunohistochemical staining

To account for the shrinkage of the tumour due to fixation, the resection specimen will be placed in a box and scanned with an MRI. From this a shrinkage factor will be calculated using the original pre-treatment MRI.

MRI of the resection specimen

On the imaging modalities the tumor volume will be delineated. This will also be done on the resection specimen. Later on the different tumour volumes will be correlated.

Tumour volume delineation and comparison

Sandra Nuyts, PhD MD

Chemo-radiotherapy (CRT) is currently the cornerstone in the management of locoregional advanced head and neck cancer (HNC). Optimization of the quality of RT is therefore an important issue, if the investigators want to improve the therapeutic index in HNC. This could be achieved by a more accurate definition of the tumor volume and by identification of radioresistant volumes within the tumor. Recent literature puts in this regard the incorporation of functional imaging (FI) in the RT treatment planning forward as a promising tool.

FI modalities provide an outstanding contrast between tumor and surrounding tissues. This is in contrast to anatomical imaging. Using anatomical imaging in RT treatment planning, sufficient margins need to be placed around the tumor volume in order to compensate for geometric uncertainties. Consequently many surrounding functional structures receive high doses of irradiation, resulting in side effects. It is expected that, using FI in RT treatment planning will make these margins smaller or even unnecessary, which will result in less irradiation of the surrounding tissues. So far only one study has reported a comparison between tumor volume on anatomical (CT and MRI) and FI (PET-CT) modalities with pathological tumor volume. This study showed indeed that the tumor volumes delineated on PET-CT correlated more to tumor volumes defined by pathology and were significantly smaller.

Furthermore, FI provides us with a deeper insight in the tumor's underlying biological activity and microstructure. These techniques can thus help to identify radioresistant subvolumes which might benefit from treatment intensification.

A validation of these FI modalities with pathology is necessary to investigate their true power in tumor delineation and in the identification of radioresistant subvolumes.

1. BACKGROUND AND SETTING

   1.1. INTRODUCTION

   Concurrent (chemo-) radiotherapy (CRT) is the current standard of care for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). The proximity of important functional structures with the tumour makes treatment however highly complex. Treatment related toxicity can be severe with xerostomia and dysphagia gravely complicating the patient's quality of life. The use of altered fractionation schedules and/or concurrent chemotherapy has resulted in substantial gains in loco-regional control, leading to significant improvements in overall survival. Although the prognosis of patients treated with RT for locally advanced HNSCC is continually improving, there are still a high number of locoregional failures.

   Using highly conformal radiotherapy the investigators can increase the therapeutic index by giving higher doses to the more radio-resistant parts of the tumour while maintaining or even reducing dose to the surrounding tissues. Functional imaging can help us to define these radio-resistant subvolumes and help us to delineate the gross tumour volume (GTV) better in the future. Positron emission tomography (PET), Diffusion weighted magnetic resonance imaging (DWI) and Dynamic contrast enhanced MRI (DCE-MRI) can give us further insight in the tumour's underlaying biological and microstructural characteristics. However, at the moment the investigators are not sure how to interpret the different imaging parameters obtained from these functional imaging modalities. Therefore, the investigators want to correlate the imaging parameters with the pathological characteristics of the tumour. On the other hand the investigators want to correlate the GTV defined on the functional imaging modalities with the pathological GTV, and see if these modalities can help us to delineate the GTV more accurately in the future.

   1.2. IMAGING MODALITIES

   1.2.1. FDG-Positron Emission Tomography (FDG-PET)

   Increased glucose metabolism is a fundamental characteristic of many malignant tumours, including HNSCC. Positron emission tomography (PET) after injection of radioactively labeled 2' fluorodeoxyglucose (18F-FDG) can help us measure and quantify this metabolism in tumours, using the standardized uptake value (SUV). Several studies have correlated high SUV prior to treatment with significantly worse outcome in HNSCC. Furthermore it appears that most local recurrences occur within the FDG-PET defined GTV. The molecular base for this is not completely understood.

   Proliferating tumour cells consume glucose at a high rate and release lactate and not CO2. This way they omit the mitochondria driven oxidative phosphorylation of glucose from the production of ATP (=Warburg-effect). Several molecular parameters have been associated with this glycolytic switch, such as activation of the hypoxia induced HIF1α and the increased presence of GLUT glucose transport proteins. So far no clear correlation was found between the presence of hypoxia and FDG-uptake.

   1.2.2. Diffusion-weighted Magnetic resonance imaging (DWI)

   Diffusion weighted magnetic resonance imaging (DWI) can characterize tissues based on the random displacement of water molecules. In biological tissues this displacement is limited by underlying tissue-specific barriers and this difference can be quantified and visualized using apparent diffusion coefficient (ADC) values. A study on 165 patients in our centre with HNSCC demonstrated that the pre-treatment ADC value is a strong and independent prognostic factor for outcome. Patients with a high ADC value respond worse to ionizing radiation than patients with a lower ADC value. There is currently no clear explanation why tumours with a higher cellular density are more radiosensitive than tumours with a low density. A number of microscopic features effect water diffusivity in tissue (presence of necrosis, cellular density, inflammation, integrity of cellular membranes). Many of these also affect the radio- and chemosensitivity of the tumours.

   1.2.3. Dynamic contrast enhanced Magnetic resonance imaging (DCE-MRI)

   Dynamic contrast enhanced MRI (DCE-MRI) is a non-invasive imaging modality which has been developed and evaluated for the characterization of vascular properties of tissues. Adequate oxygen supply is essential for the effectivity if ionizing radiation. However tumor angiogenesis is far from perfect and newly formed vessels display permeability, tortuosity and a generally poor functionality. These vascular properties could provide us insight in the aggressiveness and radiosensitivity of the tumor. Dynamic computed tomography (CT) has demonstrated that perfusion measurements can predict outcome in head and neck cancer after radiotherapy. Similarly quantitative assessment of DCE-MRI has also been correlated with response to ionizing radiation in patients with HNSCC. A recent trial on a limited number of patients correlated certain DCE-MRI parameters with intratumoural hypoxia. However, so far no spatial correlation has been done.
2. STUDY OBJECTIVES

   2.1. PRIMARY OBJECTIVES

   The main objective of this study is to correlate DWI, DCE-MRI and FDG-PET with the spatial distribution of hypoxia in patients with head and neck cancer.

   2.2. SECONDARY OBJECTIVES

   A. To correlate findings on functional imaging with intrinsic molecular parameters depicting proliferation, hypoxia and glucose metabolism.

   B. To validate the use of the hypoxia markers and the 15-gene hypoxia gene expression classifier.

   C. To compare tumour volume as derived from pathology with the volumes delineated on the several anatomical and functional imaging modalities.
3. STUDY DESIGN

   The target group for this trial is patients with a histologically proven squamous cell carcinoma of the larynx, eligible for surgery, staged T3-4. Prior to treatment patients will undergo an FDG-PET/CT and MRI with DW and DCE, dedicated for optimal visualization of the primary tumor and analysis. The imaging modalities will be performed as close to the surgery as possible (PET/CT one week before surgery; MRI one day before surgery).

   Prior to treatment, three slices on the imaging modalities will be selected by a radiologist based on their visual quality and heterogeneity of functional parameters. These regions of interest will be compared to different histopathological parameters on the resection specimen. The radiologist will also select regions, based on DWI and DCE parameters, who are suspect to be hypoxic. From these regions a biopsy will be taken.

   After total laryngectomy, the resection specimen will be oriented, and biopsy material will be obtained from the regions in the tumour that have been selected on the imaging modalities The rest of the specimen will be fixed in formaldehyde. To account for the shrinkage of the tumour due to fixation, the resection specimen will be placed in a cardboard box with an agarose solution and scanned with an MRI with T1w/T2 images. From this a shrinkage factor will be calculated comparing the delineated T1 and T2 weighted images.

   After fixation the tumour will be cut up into macroslices with a thickness of about 5mm. On each macroslice tumour volume will be delineated. Using this, the pathological tumour volume will be determined taking into account the previously determined shrinkage factor. This pathological volume will be compared to the tumour volume delineated on the imaging modalities. On the different pre-surgery functional imaging modalities, 4 separate observers will delineate the GTV. The different volumes will be compared and overlap will be calculated after 3D specimen reconstruction and registration.

   The GTV obtained from the functional imaging will be correlated with the pathological tumor volume of the resection specimen. This information will give us more insight into the true power of the investigated functional imaging techniques in determining tumour volume. This is important to assess the role of functional imaging modalities in treatment planning in the future.

   At the three levels, chosen by the radiologist on the imaging modalities, 4µm thick slices will be taken. On each level an immunohistochemical staining will be carried out (GLUT-1, CA-IX, HIF-1α, VEGF and KI 67 staining will be performed ).

   IHC will be scored according to a semiquantitative scoring system using a field analysis where each field will be assigend a score of 1-4 according to the approximate area of immunostaining (0:0%, 1:1-5%, 2: 5-15%, 3: 15-30% and 4: \>30%.
4. SAMPLE SIZE Twenty patients with squamous cell carcinoma of the larynx, planned to undergo total laryngectomy, will be included.

Pathological Validation of Functional Imaging in Head and Neck Squamous Cell Carcinoma

Pathological Validation of Functional Imaging in Head and Neck Squamous Cell Carcinoma. A Prospective, Non-commercial and Mono-centric Study

The correlation of DWI, DCE-MRI and FDG-PET with the spatial distribution of hypoxia in patients with head and neck cancer.

Flemish League Against Cancer

Universitaire Ziekenhuizen KU Leuven

Full Professor, Clinical staff member

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

philippe Lambin

Observational study based on the routine clinical treatment and diagnostic course, to correlate imaging features with outcome objectives. Outcome will evaluated as clinical response to the standard treatment and as recurrence and survival in the follow up. The study hypothesis is that data extracted form FDG-PETCT used in the routine clinical practice can predict outcomes following standard treatment.

This study will prospectively collect patients undergoing to the standard diagnostic and treatment protocol in Maastro Clinic. Any difference in the normal procedure will be adopted. The aim is to extrapolate form the PET images some features of the metabolic tumor activity to associate with different outcomes and tumor behaviours.

Prediction of Clinical Response and Outcome in Uterine Cervix Cancer

Predicting Clinical Response and Outcome After Definitive Irradiation With MRI-Guided Adaptive Brachytherapy in Uterine Cervix Cancer

* Standard Uptake Value Max (SUV- defined as the ratio of tissue radioactivity concentration (e.g. in MBq/kg=kBq/g) at time t, c(t), and the injected activity ( in MBq) at the time of injection (t=0) divided by the body weight in kg),
* Metabolic Volume (MV) calculated in cc:volume of the evaluable metabolic activity on the PET scan calculated in a specific Region of Interest (ROI) semiautomatically delineated on the primary tumor in the uterine Cervix

* Standard Uptake Value Max (SUV- defined as the ratio of tissue radioactivity concentration (e.g. in MBq/kg=kBq/g) at time t, c(t), and the injected activity ( in MBq) at the time of injection (t=0) divided by the body weight in kg),
* Ratio of Pre/Post treatment SUV MAX,

* We will apply a high throughput approach to convert medical images to minable data, where it is hypothesized that it will improve tumor characterization and treatment outcome prediction.
* Extracted imaging features consist firstly of global properties, providing information on the first order histogram of voxel intensity values within the tumor VOI.
* Local and regional textural features describing patterns and spatial distribution of voxel intensities, are calculated from respectively gray level co-occurrence and gray level run-length matrix representations. Images will be discretized before texture analysis, which allows for a direct comparison of all calculated textural features between patients. Co-occurrence and gray level run-length matrices are determined considering 26-connected voxels (i.e. voxels were considered to be neighbors in all 13 directions in three dimensions) and a distance of 1 between consecutive voxels. Features derived from the co-occurrence and gray

* GTV volume in cc contoured by 5 different observers on pretreatment scan: the difference in cc between each contour obtained will be scored
* GTV Overlapping fraction rate: the overlapping rate of GTV volume between contours

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer	NCT01621529	Infiltrating Du...		18 Years -	Centre Henri Becquerel
Predictive Value of Pet Scan With Fdg Performed During Irradiation in Patients Treated for Oesaphagus Carcinoma	NCT00934505	Oesophageal Can...		18 Years -	Centre Henri Becquerel
Study of the Fixation of Various Vectors in PET/CT in Patients With a With Lung Cancer Before and During of CRT or RT	NCT01261585	Bronchial Neopl... Carcinoma, Non-...		18 Years - 75 Years	Centre Henri Becquerel
Predictive Value of FDG-TEP During Radiotherapy or Chemo-radiotherapy in Patients With NCSC on the One-year Survival	NCT01261598	Lung Cancer NSCLC	Positron Emissi...	18 Years -	Centre Henri Becquerel
Pathological Validation of Functional Imaging in Head and Neck Squamous Cell Carcinoma	NCT01827709	Head and Neck C...	A polymerase ch... Functional imag... Immunohistochem... MRI of the rese... Tumour volume d...	18 Years -	Universitaire Ziekenhuizen KU Leuven
Prediction of Clinical Response and Outcome in Uterine Cervix Cancer	NCT01764217	Cervix Cancer		18 Years -	Maastricht Radiation Oncology
Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer	NCT01621529	Infiltrating Du...		18 Years -	Centre Henri Becquerel

Spots Global Cancer Trial Database for suv

Every month we try and update this database with for suv cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for suv

Every month we try and update this database with for suv cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for suv cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.