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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2020-03-31

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.

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Detailed Description

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Conditions

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Non-seminomatous Germ Cell Tumors Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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K5-RGD PET + FDG

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.

Group Type OTHER

K5-RGD PET

Intervention Type OTHER

Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy

FDG

Intervention Type OTHER

Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy

Interventions

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K5-RGD PET

Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy

Intervention Type OTHER

FDG

Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No