- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872221
Study of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study (STEMRI)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Toulouse, France, 31052
- Institut Claudius Regaud
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Toulouse, France, 31000
- CHU Rangueil
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
First part of the study (Surgery and Imagery):
- Surgical indication for patients who present radiological criteria of glioblastoma.
- Patient who are ≥18 years old
- Patient must have performance status between 0 and 2 on the ECOG Performance Scale
- Life expectancy ≥ 3 months
- Patient affiliated to social security regimen
- Patient has voluntarily agreed to participate by giving written informed consent for the first part of the study.
Second part of the study (Treatment and Biology):
- Histologically confirmed glioblastoma
- Patient must have performance status between 0 and 2 on the ECOG Performance Scale or 3 only is due to motor deficit.
- Life expectancy ≥ 3 months
- Patient affiliated to social security regimen
- Patient has voluntarily agreed to participate by giving written informed consent for the second part of the study.
Exclusion Criteria:
First part of the study (Surgery and Imagery):
- Patients who are not allowed to perform an MRI
- Spectroscopic exam whose results are not contributive
- Pregnant or nursing patient,
- Patients under law protection
- Patient who presents conditions that would interfere with cooperation with the requirements of the trial.
- Patient who presents medical, severe or chronic biological or psychiatric conditions not allowing his enrolment in the study, according to the investigator's opinion
Second part of the study (Treatment and Biology):
1.Biological material received in the lab more than 48 hours after surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Surgery and radio-chemotherapy
Surgery (on the basis of all preoperative multimodal MRI) followed by standard radio-chemotherapy stupp protocol
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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4,5 years
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Biologic analysis of the GBM resected samples on the RNA expression of 5 stem cells markers
Time Frame: 4,5 years
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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)
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4,5 years
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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
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4,5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to progression
Time Frame: 4,5 years
|
The time to progression is defined as the time from surgery until progression
|
4,5 years
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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)
|
4,5 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ancillary study of neurocognitive function
Time Frame: 4,5 years
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The neurocognitive function will be evaluated using the following tests:
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4,5 years
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Ancillary study of quality of life
Time Frame: 4,5 years
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Quality of life will be evaluated using EORTC questionnaire QLQ C-30 and QLQ BN20
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4,5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elisabeth MOYAL, professor, Institut Claudius Regaud
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12TETE01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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