Contribution of the Imaging to the Expression of intégrines αvβ3 for the Characterization of Residual Masses of Non-seminoma Tumors at the End of Chemotherapy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy. The investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.

Official Title
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A Prospective,Multicenter, Phase II Study to Evaluate the Contribution of the Imaging TEP to the Expression of intégrines αvβ3 for the Characterization of the Residual Masses of Non-seminoma Tumors at the End of Chemotherapy

Conditions
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Non-seminomatous Germ Cell Tumors, Metastasis

Intervention / Treatment
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* Other: K5-RGD PET
* Other: FDG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man or woman aged 18 years or more Patients with one or several ganglionic or visceral residual masses (> to 1 cm) after chemotherapy for metastatic non-seminoma testicular tumor, and for which or which a surgery is planned; Affiliate to a social security system; Signed written Informed consent Exclusion Criteria: Patient deprived of liberty as a result of a justice or administrative decision Any medical or psychological condition which could compromise the capacity of the patient to participate in the study; Previous or concomitant other cancer in 5 years except basal cell carcinomas

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: K5-RGD PET + FDG<br>Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy, with a maximal delay from end of chemotherapy of 2 months. Delay between FDG and 18F-K5-RGD PET scans will not exceed 2 weeks. | Other: K5-RGD PET<br>* Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy<br>Other: FDG<br>* Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of teratoma | Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors. | up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic profile | Number of patients having at least a tumor detected by TEP K5-RGD requiring a surgery, divided by the number of patients having actually at least a tumor (by anatomopathologie) requiring a chirurgie | up to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nuclear medicine, Positron emission tomography, avb3 integrin expression