Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastasis | — | UNRESOLVED | — |
| Non-seminomatous Germ Cell Tumors | Non-Seminomatous Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG | Other | — | UNRESOLVED |
| K5-RGD PET | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- K5-RGD PET + FDG
- 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.
- interventionNames
- Other: K5-RGD PET
- Other: FDG
Primary outcomes (1)
- measure
- Proportion of teratoma
- timeFrame
- up to 6 weeks
- description
- Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors.
Secondary outcomes (1)
- measure
- Metabolic profile
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available