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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Non-seminomatous Germ Cell Tumors
- Sponsor
- Centre Francois Baclesse
- Enrollment
- 16
- Locations
- 5
- Primary Endpoint
- Proportion of teratoma
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Proportion of teratoma
Time Frame: up to 6 weeks
Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors.
Secondary Outcomes
- Metabolic profile(up to 10 weeks)