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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02317393

Acronym

TERMATEP

Enrollment

Registered

2014-12-16

Start date

2014-12-31

Completion date

2020-03-31

Last updated

2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-seminomatous Germ Cell Tumors, Metastasis

Keywords

Nuclear medicine, Positron emission tomography, avb3 integrin expression

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.

Interventions

OTHERK5-RGD PET

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

OTHERFDG

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026