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

NCT01872221 | Completed

• 1 other identifier: 12TETE01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Glioblastoma

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  4,5 years

• 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)

  4,5 years

• Biologic analysis of the GBM resected samples for their capacity to form invasive brain tumor after orthotopic implantation of the cells in nude mice

  4,5 years

Secondary Outcomes (2)

• Time to progression

  4,5 years

• Overall survival

  4,5 years

Other Outcomes (2)

• Ancillary study of neurocognitive function

  4,5 years

• Ancillary study of quality of life

  4,5 years

Study Arms (1)

Surgery and radio-chemotherapy

EXPERIMENTAL

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

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

Interventions

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

Surgery and radio-chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (2)

CHU Rangueil

Toulouse, 31000, France

Location

Institut Claudius REGAUD

Toulouse, 31052, France

Location

Related Publications (2)

• Lemarie A, Lubrano V, Delmas C, Lusque A, Cerapio JP, Perrier M, Siegfried A, Arnauduc F, Nicaise Y, Dahan P, Filleron T, Mounier M, Toulas C, Cohen-Jonathan Moyal E. The STEMRI trial: Magnetic resonance spectroscopy imaging can define tumor areas enriched in glioblastoma stem-like cells. Sci Adv. 2023 Nov 3;9(44):eadi0114. doi: 10.1126/sciadv.adi0114. Epub 2023 Nov 3.

  PMID: 37922359 RESULT

• 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.

  PMID: 33245115 DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Elisabeth MOYAL, professor

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: June 7, 2013
• Study Start: May 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (2)