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

NCT02317393 | Completed Phase 2 DMC

• 1 other identifier: TERMATEP
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 5

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.

Conditions

Non-seminomatous Germ Cell Tumors; Metastasis

Keywords

Nuclear medicine; Positron emission tomography; avb3 integrin expression

Outcome Measures

Primary Outcomes (1)

• Proportion of teratoma

  Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors.

  up to 6 weeks

Secondary Outcomes (1)

• Metabolic profile

  up to 10 weeks

Study Arms (1)

K5-RGD PET + FDG

OTHER

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; Other: FDG

Interventions

K5-RGD PET OTHER

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

K5-RGD PET + FDG

FDG OTHER

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

K5-RGD PET + FDG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (5)

CHU

Caen, 14000, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Henri Becquerel

Rouen, France

Location

CHU Rouen

Rouen, France

Location

Institut Claudius Regaud

Toulouse, France

Location

MeSH Terms

Conditions

Nonseminomatous germ cell tumor; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas AIDE, Dr

  Centre François Baclesse, CAEN, France

  PRINCIPAL INVESTIGATOR

• Arnaud DOERFLER, Dr

  CHU Côte de Nacre, CAEN, France

  PRINCIPAL INVESTIGATOR

• Pierre VERA, Dr

  Centre Henri Becquerel, ROUEN, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: December 16, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-02

Locations

FR (5)