Non Invasive Methods for Differential Diagnosis Radionecrosis/Recurrence After Radiosurgery of Brain Metastases
Condition: Brain Metastases; Growing Lesions After Radiosurgical Treatment
MeSH terms: Neoplasm Metastasis; Brain Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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 diagnosis between relapse and radio necrosis after radiosurgery would
      allow:

        -  To perform resection of tumor relapse

        -  To treat feasable/inoperable tumor relapse with a salvage radiosurgery

        -  To avoid irradiation for patients presenting radiation necrosis

        -  To reduce the corticosteroid prescription period. Validation of non-invasive diagnostic
           tools should in fine avoid biopsy. In addition, the results of this study should help to
           better estimate the true incidence of radiation necrosis and better specify the
           predictors of this complication.

      CV-METANEC is a prospective, multicenter, open, multidisciplinary study involving the
      following departments: neurosurgery, neuroradiology, nuclear medicine and neuropathology.

      4 centers participating in the study: Groupe Hospitalier Pitié-Salpêtrière University
      Hospital, Lariboisière Hospital, Lille University Hospital of Clermont Ferrand and Toulouse
      University Hospital.

      Patients are included if they were treated by radiosurgery for one or more brain metastases.
      The interval between the radiosurgical treatment and the inclusion is at least 6 months. The
      lesion is clinically and / or MRI evolving.

      The criterion used to measure the discriminating power of the algorithm to rank the
      differential between recurrences with or without radionecrosis or only radionecrosis is the
      area under the ROC (receiver operating characteristic) curve. The inclusion of 90 subjects
      will achieve a standard deviation of the area under the curve 0.04.

      The duration of study participation will be five weeks, from inclusion until the end of
      hospitalization. Subsequently, the patient will be followed as usual.

      Inclusion D0: whether the conditions of inclusion are applied, the patient signs the consent
      form and exams before surgery are planned: SRI-MRI, examination of scintigraphy and
      anesthesia consultation.

      D15: MRI (neuroradiology) and anesthetic consultation (neurosurgery).

      D30-D33 (+/- 7 days): 3 days of hospitalization:

      D30: MRI / MRS always done before-FET PET D31: stereotactic biopsy for histological samples.
      D33: CT scan before the patient is discharged. Total study duration: 5 years
    

Intervention name(s): imaging
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: diagnostic strategy; brain metastases; radiation necrosis; relapse; PET-FET and MSR; radiosurgery