Status:
COMPLETED
Study of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 imag...
Eligibility Criteria
Inclusion
- 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
- 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):
- Biological material received in the lab more than 48 hours after surgery.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01872221
Start Date
May 1 2013
End Date
April 1 2018
Last Update
August 27 2018
Active Locations (2)
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1
CHU Rangueil
Toulouse, France, 31000
2
Institut Claudius REGAUD
Toulouse, France, 31052