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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)

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ClinicalTrials.gov Identifier: NCT02317393
Recruitment Status : Recruiting
First Posted : December 16, 2014
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse

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.


Condition or disease Intervention/treatment Phase
Non-seminomatous Germ Cell Tumors Metastasis Other: K5-RGD PET Other: FDG Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Study Start Date : December 2014
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
K5-RGD PET + FDG
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.
Other: K5-RGD PET
Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317393


Contacts
Contact: Nicolas AIDE, Pr "Dr Nicolas AIDE" <naide@baclesse.unicancer.fr>;
Contact: Jean-Michel GRELLARD, CRA jm.grellard@baclesse.fr

Locations
France
CHU Recruiting
Caen, France, 14000
Contact: Nicolas AIDE, Pr         
Principal Investigator: Nicolas AIDE, Pr         
Sub-Investigator: Arnaud DOERFLER, Dr         
Centre François Baclesse Recruiting
Caen, France, 14076
Contact: Florence JOLY, Pr       f.joly@baclesse.unicancer.fr   
Principal Investigator: Florence JOLY, Pr         
Sub-Investigator: Laura MOISE, Dr         
Centre Henri Becquerel Not yet recruiting
Rouen, France
Contact: Pierre VERA, Pr         
Principal Investigator: Pierre VERA, Pr         
CHU Rouen Recruiting
Rouen, France
Contact: PFISTER Christian, Pr         
Principal Investigator: PFISTER Christian, Pr         
Institut Claudius Regaud Recruiting
Toulouse, France
Contact: Christine CHEVREAU, MD         
Principal Investigator: Christine CHEVREAU, MD         
Sub-Investigator: Loic MOURREY, MD         
Sub-Investigator: Ewa COTTURA, MD         
Sub-Investigator: Carlos GOMEZ-ROCA, MD         
Sub-Investigator: Sarah ZAHI, MD         
Sub-Investigator: Slimane ZERDOUD, MD         
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Principal Investigator: Nicolas AIDE, Dr Centre François Baclesse, CAEN, France
Principal Investigator: Arnaud DOERFLER, Dr CHU Côte de Nacre, CAEN, France
Principal Investigator: Pierre VERA, Dr Centre Henri Becquerel, ROUEN, France

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT02317393     History of Changes
Other Study ID Numbers: TERMATEP
First Posted: December 16, 2014    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Keywords provided by Centre Francois Baclesse:
Nuclear medicine
Positron emission tomography
avb3 integrin expression

Additional relevant MeSH terms:
Testicular Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders