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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery and radio-chemotherapy | Experimental | Surgery (on the basis of all preoperative multimodal MRI) followed by standard radio-chemotherapy stupp protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery (based on preoperative multimodal MRI) followed by the standard radio-chemotherapy stupp protocol | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 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 | 4,5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | The time to progression is defined as the time from surgery until progression | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Ancillary study of neurocognitive function | The neurocognitive function will be evaluated using the following tests:
| 4,5 years |
Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth MOYAL, professor | Institut Claudius Regaud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Rangueil | Toulouse | 31000 | France | |||
| Institut Claudius REGAUD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37922359 | Result | Lemarie A, Lubrano V, Delmas C, Lusque A, Cerapio JP, Perrier M, Siegfried A, Arnauduc F, Nicaise Y, Dahan P, Filleron T, Mounier M, Toulas C, Cohen-Jonathan Moyal E. The STEMRI trial: Magnetic resonance spectroscopy imaging can define tumor areas enriched in glioblastoma stem-like cells. Sci Adv. 2023 Nov 3;9(44):eadi0114. doi: 10.1126/sciadv.adi0114. Epub 2023 Nov 3. | |
| 33245115 |
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| 4,5 years |
| Ancillary study of quality of life | Quality of life will be evaluated using EORTC questionnaire QLQ C-30 and QLQ BN20 | 4,5 years |
| Toulouse |
| 31052 |
| France |
| Pinto G, Saenz-de-Santa-Maria I, Chastagner P, Perthame E, Delmas C, Toulas C, Moyal-Jonathan-Cohen E, Brou C, Zurzolo C. Patient-derived glioblastoma stem cells transfer mitochondria through tunneling nanotubes in tumor organoids. Biochem J. 2021 Jan 15;478(1):21-39. doi: 10.1042/BCJ20200710. |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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