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NCT Number: NCT01872221

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

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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Rangueil, Toulouse, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

Primary outcomes

  1. 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.

  2. Biologic analysis of the GBM resected samples on the RNA expression of 5 stem cells markers

    Time frame: 4,5 years

    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)

  3. 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 outcomes

  1. Time to progression

    Time frame: 4,5 years

    The time to progression is defined as the time from surgery until progression

  2. 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)

Other outcomes

  1. Ancillary study of neurocognitive function

    Time frame: 4,5 years

    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.

  2. Ancillary study of quality of life

    Time frame: 4,5 years

    Quality of life will be evaluated using EORTC questionnaire QLQ C-30 and QLQ BN20

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: STEMRI

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2013
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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