Clinical trial · Interventional
Non Invasive Methods for Differential Diagnosis Radionecrosis/Recurrence After Radiosurgery of Brain Metastases
Non Invasive Methods for Differential Diagnosis Radionecrosis/Recurrence After Radiosurgery of Brain Metastases. CV-METANEC
- 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 multicenter study is to assess a diagnostic strategy concerning differential diagnosis between radiation necrosis and relapse in brain metastases treated with radiosurgery. Two non-invasive tests - positron emission tomography (PET) with 1F-fluoro-ethyl-tyrosine (FET) and magnetic resonance spectroscopy (MRS) - will be compared to histology in a cohort of patients presenting growing lesions 6 months after radiosurgical treatment. The results of this study should help to earlier diagnosis of recurrences after radiosurgery and to perform an appropriate treatment for 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 |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Growing Lesions After Radiosurgical Treatment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imaging | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- diagnostic imaging strategy
- description
- PET-FET (positron emission tomography using 1-Fluoro-Ethyl-Tyrosine) and MSR (magnetic resonance spectroscopy) before biopsy
- interventionNames
- Other: imaging
Primary outcomes (5)
- measure
- the choline /N-acetyl aspartate ratio at MR spectroscopy
- timeFrame
- Day 30
- measure
- the lipid / lactate ratio at MR spectroscopy
- timeFrame
- Day 30
- measure
- peak creatine at MR spectroscopy
- timeFrame
- Day 30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * age between 18 and 75 years. * Patient treated with radiosurgery for one or more brain metastases Free -Intervally between radiosurgical treatment and inclusion in the study at least four months. * Lesion (S) treated (s) and followed (s) with the criteria for a clinically active lesion (progressive deficit, seizures, intracranial hypertension steroid-dependent) and / or MRI (increased volume of contrast enhancement with peri-lesional edema and mass effect on two successive examinations at 1 month interval). * Karnofsky index\> 50. * Prognostic compatible for survival with a follow-up at least three months from the date of inclusion. * Effective contraception for women of childbearing potential or negative pregnancy test within 72 hours. * Signed informed consent obtain * Affiliation to the social security system Exclusion Criteria: * Contraindication to MRI examination * Clearance of the creatinine incompatible with the injection of gadolinium * No potential follow-up in middle or long term * Pregnancy
References
Publications (0)
Data not yet available