Back to resultsContribution 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)
Primary Purpose
Non-seminomatous Germ Cell Tumors, Metastasis
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
K5-RGD PET
FDG
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-seminomatous Germ Cell Tumors focused on measuring Nuclear medicine, Positron emission tomography, avb3 integrin expression
Eligibility 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
Sites / Locations
- CHU
- Centre François Baclesse
- Centre Henri Becquerel
- CHU Rouen
- Institut Claudius Regaud
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
K5-RGD PET + FDG
Arm 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.
Outcomes
Primary Outcome Measures
Proportion of teratoma
Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors.
Secondary Outcome Measures
Metabolic profile
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02317393
Brief Title
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
Acronym
TERMATEP
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 Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-seminomatous Germ Cell Tumors, Metastasis
Keywords
Nuclear medicine, Positron emission tomography, avb3 integrin expression
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
K5-RGD PET + FDG
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
K5-RGD PET
Intervention Description
Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy
Intervention Type
Other
Intervention Name(s)
FDG
Intervention Description
Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy
Primary Outcome Measure Information:
Title
Proportion of teratoma
Description
Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors.
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Metabolic profile
Description
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
Time Frame
up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas AIDE, Dr
Organizational Affiliation
Centre François Baclesse, CAEN, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnaud DOERFLER, Dr
Organizational Affiliation
CHU Côte de Nacre, CAEN, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre VERA, Dr
Organizational Affiliation
Centre Henri Becquerel, ROUEN, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
CHU Rouen
City
Rouen
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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