TERMATEP: 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
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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
|
Outcome Measures
Primary Outcome Measures
- Proportion of teratoma [up to 6 weeks]
Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors.
Secondary Outcome Measures
- Metabolic profile [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
Eligibility Criteria
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;
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Affiliate to a social security system;
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Signed written Informed consent
Exclusion Criteria:
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Patient deprived of liberty as a result of a justice or administrative decision
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Any medical or psychological condition which could compromise the capacity of the patient to participate in the study;
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Previous or concomitant other cancer in 5 years except basal cell carcinomas
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU | Caen | France | 14000 | |
| 2 | Centre François Baclesse | Caen | France | 14076 | |
| 3 | Centre Henri Becquerel | Rouen | France | ||
| 4 | CHU Rouen | Rouen | France | ||
| 5 | Institut Claudius Regaud | Toulouse | France |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TERMATEP