Back to resultsStudy of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study (STEMRI)
Primary Purpose
Glioblastoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surgery (based on preoperative multimodal MRI) followed by the standard radio-chemotherapy stupp protocol
Sponsored by
About this trial
This is an interventional other trial for Glioblastoma focused on measuring Glioblastoma, Spectroscopy, MRI, Glioma stem cells, Surgery, Radioresistance
Eligibility Criteria
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.
Sites / Locations
- CHU Rangueil
- Institut Claudius REGAUD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery and radio-chemotherapy
Arm Description
Surgery (on the basis of all preoperative multimodal MRI) followed by standard radio-chemotherapy stupp protocol
Outcomes
Primary Outcome Measures
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.
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)
Biologic analysis of the GBM resected samples for their capacity to form invasive brain tumor after orthotopic implantation of the cells in nude mice
Secondary Outcome Measures
Time to progression
The time to progression is defined as the time from surgery until progression
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01872221
Brief Title
Study of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study
Acronym
STEMRI
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 Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Glioblastoma, Spectroscopy, MRI, Glioma stem cells, Surgery, Radioresistance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery and radio-chemotherapy
Arm Type
Experimental
Arm Description
Surgery (on the basis of all preoperative multimodal MRI) followed by standard radio-chemotherapy stupp protocol
Intervention Type
Procedure
Intervention Name(s)
Surgery (based on preoperative multimodal MRI) followed by the standard radio-chemotherapy stupp protocol
Primary Outcome Measure Information:
Title
Biologic analysis of the GBM resected samples for the capacity to form neurospheres in vitro
Description
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
Title
Biologic analysis of the GBM resected samples on the RNA expression of 5 stem cells markers
Description
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
Title
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
Secondary Outcome Measure Information:
Title
Time to progression
Description
The time to progression is defined as the time from surgery until progression
Time Frame
4,5 years
Title
Overall survival
Description
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
Other Pre-specified Outcome Measures:
Title
Ancillary study of neurocognitive function
Description
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
Title
Ancillary study of quality of life
Description
Quality of life will be evaluated using EORTC questionnaire QLQ C-30 and QLQ BN20
Time Frame
4,5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth MOYAL, professor
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Institut Claudius REGAUD
City
Toulouse
ZIP/Postal Code
31052
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33245115
Citation
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.
Results Reference
derived
Learn more about this trial
Study of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study
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