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Search / Trial NCT02636634

Non Invasive Methods for Differential Diagnosis Radionecrosis/Recurrence After Radiosurgery of Brain Metastases

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 17, 2015

Trial Information

Current as of August 02, 2025

Completed

Keywords

Diagnostic Strategy Brain Metastases Radiation Necrosis Relapse Pet Fet And Msr Radiosurgery

ClinConnect Summary

The purpose of the study is to assess a diagnostic strategy by monitoring brain metastases after radio surgical treatment . Data from two non-invasive techniques: PET-FET (positron emission tomography using 1-Fluoro-Ethyl-Tyrosine) and MSR (magnetic resonance spectroscopy) will be compared to histological examination (gold standard) in patients with active persistent and increased lesion 4 months after radiosurgery. The study should develop a decision-making algorithm based on non-invasive tests and allow improving the length and quality of life of these patients.

Early differential diagno...

Gender

ALL

Eligibility criteria

  • 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

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Charles-Ambroise VALERY, MD, PhD

Principal Investigator

CHU Pitié-Salpêtrière - Service de Neurochirurgie du Pr Philippe Cornu - Babinsky

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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