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

NCT02636634 | Completed Phase 3 DMC

• 2 other identifiers: P0712432009-014458-14
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Brain Metastases; Growing Lesions After Radiosurgical Treatment

Keywords

diagnostic strategy; brain metastases; radiation necrosis; relapse; PET-FET and MSR; radiosurgery

Outcome Measures

Primary Outcomes (5)

• the choline /N-acetyl aspartate ratio at MR spectroscopy

  Day 30

• the lipid / lactate ratio at MR spectroscopy

  Day 30

• peak creatine at MR spectroscopy

  Day 30

• lesional tissue / normal tissue ratio at PET with FET

  Day 30

• Histological result at biopsy

  histology as the gold standard for the diagnostic between radiation necrosis and relapse

  Day 31

Study Arms (1)

diagnostic imaging strategy

OTHER

PET-FET (positron emission tomography using 1-Fluoro-Ethyl-Tyrosine) and MSR (magnetic resonance spectroscopy) before biopsy

Other: imaging

Interventions

imaging OTHER

diagnostic imaging strategy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 75 years.
• 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.
• Effective contraception for women of childbearing potential or negative pregnancy test within 72 hours.
• Signed informed consent obtain
• Affiliation to the social security system

You may not qualify if:

• Contraindication to MRI examination
• Clearance of the creatinine incompatible with the injection of gadolinium
• No potential follow-up in middle or long term
• Pregnancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, 75013, France

Location

MeSH Terms

Conditions

Brain Neoplasms; Recurrence

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Charles-Ambroise VALERY, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 22, 2015
• Study Start: June 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 11, 2016

Record last verified: 2016-04

Locations

FR (1)