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 (TERMATEP)

July 8, 2020 updated by: Centre Francois Baclesse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14076
        • Centre François Baclesse
      • Caen, France, 14000
        • CHU
      • Rouen, France
        • CHU Rouen
      • Rouen, France
        • Centre Henri Becquerel
      • Toulouse, France
        • Institut Claudius Regaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: K5-RGD PET
Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy
Other: FDG
Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

December 15, 2014

First Posted (Estimate)

December 16, 2014

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TERMATEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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