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


Condition: Non-seminomatous Germ Cell Tumors, Metastasis

Intervention:

  • Other: K5-RGD PET
  • Other: FDG

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02317393

Sponsor: Centre Francois Baclesse

Primary Outcome Measures:

  • Measure: Proportion of teratoma
  • Time Frame: up to 6 weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Metabolic profile
  • Time Frame: up to 10 weeks
  • Safety Issue:

Estimated Enrollment: 19

Study Start Date: December 2014

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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

Contact:

  • Nicolas AIDE, Pr
  • “Dr Nicolas AIDE” <
    >;

Locations:

  • CHU
  • Caen 14000 France
  • Centre François Baclesse
  • Caen 14076 France
  • Centre Henri Becquerel
  • Rouen France
  • CHU Rouen
  • Rouen France
  • Institut Claudius Regaud
  • Toulouse France

View trial on ClinicalTrials.gov


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