- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Julien BERTHILLER
- Numero di telefono: 04 27 85 63 01
- Email: julien.berthiller@chu-lyon.fr
Backup dei contatti dello studio
- Nome: Thiébaud PICART
- Numero di telefono: 04 72 38 49 76
- Email: thiebaud.picart@chu-lyon.fr
Luoghi di studio
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Bron, Francia, 69800
- Hospices Civils de Lyon
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Contatto:
- Thiébaud PICART, MCU PH
- Numero di telefono: 04 72 38 49 76
- Email: thiebaud.picart@chu-lyon.fr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: magnetoencephalography (MEG)
Every patients eligible for a glioma resection surgery
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Eligible patients will undergo a complete Magnetoencephalography, of approximatively 45min
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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.
Lasso di tempo: At baseline and during the 10 days prior to the date of surgery, according to the standard of care.
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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.
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At baseline and during the 10 days prior to the date of surgery, according to the standard of care.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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).
Lasso di tempo: At baseline and during the 10 days prior to the date of surgery, according to the standard of care.
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Radiological patterns of areas identified by MEG, based on preoperative brain Magnetic resonance imaging (MRI) (morphological and functional)
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At baseline and during the 10 days prior to the date of surgery, according to the standard of care.
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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.
Lasso di tempo: At baseline and during the 10 days prior to the date of surgery, according to the standard of care.
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Survival of patients with residual High Frequency Channel/ Low Frequency Channel (HFC/LFC) areas on postoperative MRI and survival of patients without such areas.
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At baseline and during the 10 days prior to the date of surgery, according to the standard of care.
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 69HCL26_0020
- 2026-A01156-45 (Altro identificatore: ID-RCB)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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