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

Glioblastoma Clinical Trial

— STEMRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872221
• Other study ID #: 12TETE01
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: April 2018

Study information

• Verified date: August 2018
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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

Locations

Country	Name	City	State
France	CHU Rangueil	Toulouse
France	Institut Claudius REGAUD	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ancillary study of neurocognitive function	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.	4,5 years
Other	Ancillary study of quality of life	Quality of life will be evaluated using EORTC questionnaire QLQ C-30 and QLQ BN20	4,5 years
Primary	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
Primary	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
Primary	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	Time to progression	The time to progression is defined as the time from surgery until progression	4,5 years
Secondary	Overall survival	The overall survival is defined as the time from surgery until death from any cause or last of follow-up news (censored data)	4,5 years