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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 (STEMRI)

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ClinicalTrials.gov Identifier: NCT01872221
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

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.


Condition or disease Intervention/treatment Phase
Glioblastoma Procedure: Surgery (based on preoperative multimodal MRI) followed by the standard radio-chemotherapy stupp protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study
Study Start Date : May 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surgery and radio-chemotherapy
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872221


Locations
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France
CHU Rangueil
Toulouse, France, 31000
Institut Claudius REGAUD
Toulouse, France, 31052
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
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Principal Investigator: Elisabeth MOYAL, professor Institut Claudius Regaud

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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01872221     History of Changes
Other Study ID Numbers: 12TETE01
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

Keywords provided by Institut Claudius Regaud:
Glioblastoma
Spectroscopy
MRI
Glioma stem cells
Surgery
Radioresistance

Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue