NCT01872221

Study of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective biomedical study of interventional type which includes 16 patients on 52 months (24 months of inclusion and 28 months of follow up). This pilot study, combining a metabolic imaging approach (Proton Magnetic Resonance Spectroscopy = 1HMRSI) and a biological one, will be performed in patients harbouring a Glioblastoma (GBM)to determine whether MRI markers of aggressiveness (CNI2) are associated with specific biological patterns as regards to GBMSC (GBM contains tumor stem cell). In the first part of the study, patients with radiological criteria of GBM amenable to surgical resection will be included ; pre-operative multimodal MRI scans will be done and all data acquired (including H1MRS and DTI data) will be integrated in the image-guided surgical device (ie neuronavigation system) to be used intraoperatively. During tumor resection, tissue samples will be individualized, based on their multimodal imaging characteristics and sent to the radiobiology laboratory INSERM for biological analysis. After surgery, patient will be treated by the standard radio-chemotherapy stupp protocol and will be followed according to standard practices; multimodal MRI will be performed every 2 months during the first year and then every 3 months until progression.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
PROCEDURE	Surgery (based on preoperative multimodal MRI) followed by the standard radio-chemotherapy stupp protocol

Timeline

• Start date: 2013-05-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2013-06-07
• Last updated: 2026-04-14

Locations

2 sites across 1 country: France