68Ga-NODAGA-RGD PET/ CT for Tumoral Neoangiogenesis

Study Overview
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Brief Summary
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This study will assess the potential of the 68Ga-NODAGA-RGD for the evaluation of neoangiogenesis in patients followed for a neoplastic pathology and for whom a18F-FDG (or 18F-FET for gliomas) is indicated for initial extension evaluation or suspicion of recurrent tumor.

Detailed Description
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The purpose of this study is to assess the value of 68Ga-NODAGA-RGD PET/CT for detection of neoangiogenesis at level of neoplastic processes, in patients, compared to 18F-FDG PET/CT (tumors other than glioma) or 18F-FET PET/CT (patients affected by glioma) and to determine the respective diagnostic contribution of every technique. Every patient will undergo a routine 18F-FDG (or 18F-FET) PET/CT followed by a 68Ga-NODAGA-RGD PET / CT specific for the study within the next 7 days. (each image procedure duration: 2h) The criteria of primary evaluation for each of the techniques will be defined: On the images of PET/CT: SUVmax, SUVmoyen, VOI ( mL ), SUV41 % ratio [mean SUV of pixels ≥ 41 % of the SUVmax] of lesions / SUV On the images of CT: size of the lesions measured in 3D (axial, coronal and sagittal), density in Hounsfield unit (HU) The 18F-FDG/18F-FET and 68Ga-NODAGA-RGD PET / CTs will be analyzed at first separately then will be compared according to the methods described in the analysis

Official Title
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Value of PET/ CT in the 68Ga-NODAGA-RGD for the Evaluation of the Tumoral Neoangiogenesis

Conditions
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Pathological Angiogenesis

Intervention / Treatment
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* Drug: 68Ga-NODAGA-RGD PET/CT
* Radiation: 18F-FDG PET/CT
* Radiation: 18F-FET PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≤ 85 years old Karnofsky index: ≥ 80% Patients presenting a neoplasic pathology, histologically proven, known to have expressed integrin αvβ3and for which a 18F-FDG (or a 18F-FETfor glioma) is indicated : (1) glioma (WHO I, II-IV), (2) malignant melanoma, (3) cancer of upper respiratory tract, (4) breast cancer,(5) bone metastasis, (6) ovarian cancer, (7) lung cancer,(8) non-Hodgkinian malignant lymphoma with extra- lymphatic nodes extension, (9) neuroendocrine tumors, (10) pancreatic cancer,(11) oesophagus cancer,(12) stomach cancer. 10 patients will be included per type of cancer. Informed consent signed Exclusion Criteria: Incapacity to sign the informed consent Pregnancy, breastfeeding Age <18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs<br>Active Comparator: 68Ga-NODAGA-RGD radiotracer All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT or a 18F-FET PET/CT | Drug: 68Ga-NODAGA-RGD PET/CT<br>* 200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images acquired on all body . For glioma, images acquired centred on the skull<br>Radiation: 18F-FDG PET/CT<br>* 3.5 MBq/kg 18F-FDG will be administered i.v. and images acquired on all body<br>Radiation: 18F-FET PET/CT<br>* 200 MBq 18F-FET will be administered i.v. and images acquired centred on the skull<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of each method of imaging for detection of tumors | To compare the capacity of each of the techniques and their combination to detect tumors, to determine the composition of these tumors (neoangiogenesis, metabolism, necrosis), their extension, the changes due to treatment | within 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROC analysis and comparison of areas under the curve | A ROC analysis will be realized as well as a comparison of AUCs, to determine the superiority of a method compared to the other one, using a parametric test comparing of the AUC curves and ROC curves respectively by an established algorithm. The criteria of interpretation and positivity will be defined in a standard way on the images 18F-FDG / 18F-FET and 68Ga-NODAGA-RGD. | Within 10 days | 
| Comparison 68Ga-NODAGA-RGD to standard routine extension imaging assessments | The sensibility for detection of tumor by the 68Ga-NODAGA-RGD will be assessed and compared with the standard routine extension assessements including 18F-FDG PET/CT or18F-FET PET/CT, CT or any other complementary exam (US, MRI) | within 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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68Ga-NODAGA-RGD, 18F-FDG, 18F-FET, PET/CT, neoangiogenesis