Clinical Trial: 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 Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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-sem

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.


Detailed Summary:
Sponsor: Centre Francois Baclesse

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Metabolic profile [ Time Frame: up to 10 weeks ]

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


Original Secondary Outcome: Same as current

Information By: Centre Francois Baclesse

Dates:
Date Received: August 25, 2014
Date Started: December 2014
Date Completion:
Last Updated: August 11, 2016
Last Verified: July 2016