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Completed

NCT Number: NCT02317393

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

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.

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Key information

Conditions

Non-seminomatous Germ Cell Tumors Metastasis Neoplasm Metastasis Neoplasms Neoplastic Processes Nonseminomatous germ cell tumor Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU, Caen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

K5-RGD PET

Other

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

FDG

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Official study 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

Acronym: TERMATEP

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2014
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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