An interventional study of Surgery (based on preoperative multimodal MRI) followed by the standard radio-chemotherapy stupp protocol in Glioblastoma, sponsored by Institut Claudius Regaud. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Other
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 21 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
First part of the study (Surgery and Imagery):
Second part of the study (Treatment and Biology):
Exclusion Criteria:
First part of the study (Surgery and Imagery):
Second part of the study (Treatment and Biology):
1.Biological material received in the lab more than 48 hours after surgery.
Surgery (on the basis of all preoperative multimodal MRI) followed by standard radio-chemotherapy stupp protocol
Procedure: Surgery (based on preoperative multimodal MRI) followed by the standard radio-chemotherapy stupp protocol
Biologic analysis of the GBM resected samples for the capacity to form neurospheres in vitro
comparison CNI2 versus nCNI areas on the capacity to form neurospheres (yes or no) in vitro in stem cells medium up to 5 passages.
Time frame: 4,5 years
Biologic analysis of the GBM resected samples on the RNA expression of 5 stem cells markers
comparison CNI2 versus nCNI areas on the following criteria : scoring from 0 to 5 according to the RNA expression of 5 stem cells markers (CD133, Nestine, Sox2, Olig2 and Musashi)
Time frame: 4,5 years
Biologic analysis of the GBM resected samples for their capacity to form invasive brain tumor after orthotopic implantation of the cells in nude mice
Time frame: 4,5 years
Time to progression
The time to progression is defined as the time from surgery until progression
Time frame: 4,5 years
Overall survival
The overall survival is defined as the time from surgery until death from any cause or last of follow-up news (censored data)
Time frame: 4,5 years
Ancillary study of neurocognitive function
The neurocognitive function will be evaluated using the following tests: * trail making test * stroop color test * line-bissection task * Subtests of the WAISIII * MT 86 (Joanette 1992) * HDAE (BDAE) (Goodglass 1972) * MEC (Joanette 2004) * ECOSSE (Lecocq 1996) Quality of life will be evaluated using EORTC questionnaire QLQ C-30 and QLQ BN20.
Time frame: 4,5 years
Ancillary study of quality of life
Quality of life will be evaluated using EORTC questionnaire QLQ C-30 and QLQ BN20
Time frame: 4,5 years
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Institut Claudius Regaud