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)

Centre Francois Baclesse

Status and phase: Completed; Phase 2

Conditions: Non-seminomatous Germ Cell Tumors; Metastasis

Treatments: Other: K5-RGD PET; Other: FDG

Study type: Interventional

Funder types: Other

Identifiers

NCT02317393

TERMATEP

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

K5-RGD PET + FDG

Other group

Description:

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.

Treatment:

Other: K5-RGD PET

Other: FDG