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

Phase 2

Completed

• Conditions: Non-seminomatous Germ Cell Tumors; Metastasis
• Interventions: Other: K5-RGD PET; Other: FDG

• Registration Number: NCT02317393
• Lead Sponsor: Centre Francois Baclesse

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-08-25
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-16
• Status Verified: 2020-02
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
K5-RGD PET + FDG	K5-RGD PET	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.
K5-RGD PET + FDG	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.

Primary Outcome Measures

Name	Time	Method
Proportion of teratoma	up to 6 weeks	Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors.

Secondary Outcome Measures

Name	Time	Method
Metabolic profile	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

Trial Locations

Locations (5)

CHU; 🇫🇷 Caen, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

CHU Rouen; 🇫🇷 Rouen, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France