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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)

C

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)

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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