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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Biologic analysis of the GBM resected samples for the capacity to form neurospheres in vitro

Outcome 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.

Outcome Time Frame:

4,5 years

Safety Issue:

No

Principal Investigator

Elisabeth MOYAL, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

12TETE01

NCT ID:

NCT01872221

Start Date:

May 2013

Completion Date:

September 2017

Related Keywords:

  • Glioblastoma
  • Glioblastoma
  • Spectroscopy
  • MRI
  • Glioma stem cells
  • Surgery
  • Radioresistance
  • Glioblastoma

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