Study of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study (STEMRI)
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|ClinicalTrials.gov Identifier: NCT01872221|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : August 27, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Procedure: Surgery (based on preoperative multimodal MRI) followed by the standard radio-chemotherapy stupp protocol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||April 2018|
Experimental: Surgery and radio-chemotherapy
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 [ Time Frame: 4,5 years ]comparison CNI2 versus nCNI areas on the capacity to form neurospheres (yes or no) in vitro in stem cells medium up to 5 passages.
- Biologic analysis of the GBM resected samples on the RNA expression of 5 stem cells markers [ Time Frame: 4,5 years ]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)
- 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 [ Time Frame: 4,5 years ]The time to progression is defined as the time from surgery until progression
- Overall survival [ Time Frame: 4,5 years ]The overall survival is defined as the time from surgery until death from any cause or last of follow-up news (censored data)
- Ancillary study of neurocognitive function [ Time Frame: 4,5 years ]
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.
- Ancillary study of quality of life [ Time Frame: 4,5 years ]Quality of life will be evaluated using EORTC questionnaire QLQ C-30 and QLQ BN20
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872221
|Toulouse, France, 31000|
|Institut Claudius REGAUD|
|Toulouse, France, 31052|
|Principal Investigator:||Elisabeth MOYAL, professor||Institut Claudius Regaud|