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Study of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

First part of the study (Surgery and Imagery): 1. Surgical indication for patients who present radiological criteria of glioblastoma. 2. Patient who are ≥18 years old. 3. Patient must have performance status between 0 and 2 on the ECOG Performance Scale. 4. Life expectancy ≥ 3 months. 5. Patient affiliated to social security regimen. 6. 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): 1. Histologically confirmed glioblastoma. 2. Patient must have performance status between 0 and 2 on the ECOG Performance Scale or 3 only is due to motor deficit. 3. Life expectancy ≥ 3 months. 4. Patient affiliated to social security regimen. 5. 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): 1. Patients who are not allowed to perform an MRI. 2. Spectroscopic exam whose results are not contributive. 3. Pregnant or nursing patient, 4. Patients under law protection. 5. Patient who presents conditions that would interfere with cooperation with the requirements of the trial. 6. 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01872221
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut Claudius Regaud
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Elisabeth MOYAL, professor
Principal Investigator Affiliation	Institut Claudius Regaud
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Completed
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Arms & Interventions

Arms

Experimental: Surgery and radio-chemotherapy

Surgery (on the basis of all preoperative multimodal MRI) followed by standard radio-chemotherapy stupp protocol

Interventions

Procedure: - Surgery (based on preoperative multimodal MRI) followed by the standard radio-chemotherapy stupp protocol

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Rangueil, Toulouse, France

Status

Address

CHU Rangueil

Toulouse, , 31000

Institut Claudius REGAUD, Toulouse, France