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

Metastasis Clinical Trial

— TERMATEP  

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-seminoma Tumors at the End of Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317393
• Other study ID #: TERMATEP
• Status: Completed
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: March 2020

Study information

• Verified date: February 2020
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastasis
• Neoplasms, Germ Cell and Embryonal
• Non-seminomatous Germ Cell Tumors

Intervention

Other:
• K5-RGD PET
Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy
• FDG
Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	CHU	Caen
France	Centre Henri Becquerel	Rouen
France	CHU Rouen	Rouen
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of teratoma	Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors.	up to 6 weeks
Secondary	Metabolic profile	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