- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07616726
Exploration and Characterization Ofintratumoral Electrophysiological Heterogeneity in Gliomas Using Magnetoencephalography (GLIOMEG)
With more than 3,000 new cases per year in France, malignant gliomas are the most common malignant brain tumors in adults.
Treatment consists of surgical removal when possible. If this is not possible, a biopsy is performed to obtain a definitive anatomical and molecular diagnosis. Standard medical management after removal or biopsy is based on radio-chemotherapy. Despite this multimodal treatment, progression is the norm due to the invasive nature of these tumors. The prognosis remains very poor, with a median overall survival of around 18 months for glioblastomas.
Recent preliminary data indicate that magnetoencephalography (MEG) recordings can identify functional heterogeneity within a glioma. Functional analysis of these two types of areas has shown that the expression of synaptogenic factors is increased in areas of high functional connectivity compared to areas of low functional connectivity. Areas of high functional connectivity are more aggressive and more resistant to treatment.
In general, gliomas are characterized by a high degree of inter- and intra-tumoral heterogeneity. The latter has been well characterized at the transcriptomic level, and several distinct cell subpopulations have been described (classical, mesenchymal, proneural) This intra-tumoral heterogeneity is one of the factors contributing to resistance to current therapies, but it remains incompletely understood and explored. MEG is a tool capable of exploring intra- and inter-tumor heterogeneity from an electrophysiological perspective. This represents an original approach that will provide a better understanding of intra-tumor heterogeneity and lead to new therapeutic perspectives.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julien BERTHILLER
- Phone Number: 04 27 85 63 01
- Email: julien.berthiller@chu-lyon.fr
Study Contact Backup
- Name: Thiébaud PICART
- Phone Number: 04 72 38 49 76
- Email: thiebaud.picart@chu-lyon.fr
Study Locations
-
-
-
Bron, France, 69800
- Hospices Civils de Lyon
-
Contact:
- Thiébaud PICART, MCU PH
- Phone Number: 04 72 38 49 76
- Email: thiebaud.picart@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female aged over 18
- With a newly diagnosed malignant glioma based on brain imaging
- Eligible for surgical removal
- Having given their consent
Exclusion Criteria:
- Contraindications to Magnetic resonance imaging (MRI) (claustrophobia, metallic implants, particularly intraocular implants, pacemakers)
- Contraindications to magnetoencephalography (MEG) (metallic implants in the mouth-dentures, fillings, crowns)
- Coagulation disorders
- Pregnancy, breastfeeding, or patients not using effective contraception
- Subjects participating in another interventional study with an exclusion period still in progress at the time of pre-inclusion, etc.
- Subjects deprived of their liberty by judicial or administrative decision
- Subjects receiving psychiatric care
- Subjects admitted to a health or social care facility for purposes other than research
- Adult subjects subject to legal protection measures (guardianship, curatorship)
- Subjects not affiliated with a social security system or beneficiaries of a similar system
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: magnetoencephalography (MEG)
Every patients eligible for a glioma resection surgery
|
Eligible patients will undergo a complete Magnetoencephalography, of approximatively 45min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the technical feasibility of studying tumor electrophysiological heterogeneity using magnetoencephalography (MEG) in a series of patients with glioma at the initial stage of treatment.
Time Frame: At baseline and during the 10 days prior to the date of surgery, according to the standard of care.
|
Percentage of patients with a complete and usable magnetoencephalography (MEG) recording, allowing intra- and peri-tumoral electrophysiological data to be collected and resting functional connectivity to be studied for all areas of the brain.
|
At baseline and during the 10 days prior to the date of surgery, according to the standard of care.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Define the radiological characteristics of the different types of areas of interest identified by MEG by comparing MEG mapping and preoperative MRI (anatomical and functional).
Time Frame: At baseline and during the 10 days prior to the date of surgery, according to the standard of care.
|
Radiological patterns of areas identified by MEG, based on preoperative brain Magnetic resonance imaging (MRI) (morphological and functional)
|
At baseline and during the 10 days prior to the date of surgery, according to the standard of care.
|
|
Define the prognostic impact of ablation of areas with different electrophysiological properties, using an analysis that integrates MEG mapping data, post-operative MRI data, and survival data.
Time Frame: At baseline and during the 10 days prior to the date of surgery, according to the standard of care.
|
Survival of patients with residual High Frequency Channel/ Low Frequency Channel (HFC/LFC) areas on postoperative MRI and survival of patients without such areas.
|
At baseline and during the 10 days prior to the date of surgery, according to the standard of care.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL26_0020
- 2026-A01156-45 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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