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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K5-RGD PET + FDG | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K5-RGD PET | Other | Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of teratoma | Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors. | up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Caen | 14000 | France | |||
| Centre François Baclesse |
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| FDG | Other | Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy |
|
| Caen |
| 14076 |
| France |
| Centre Henri Becquerel | Rouen | France |
| CHU Rouen | Rouen | France |
| Institut Claudius Regaud | Toulouse | France |
| ID | Term |
|---|---|
| C537844 | Nonseminomatous germ cell tumor |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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