Noninvasive detection of IDH mutations in gliomas using MRI
Magnetic Resonance Spectroscopy Markers of Glioma Genomics
This study is trying to see if a special MRI can help find IDH mutations in brain tumors called gliomas to better guide treatment for patients with these tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT05700071 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on the noninvasive detection of isocitrate dehydrogenase (IDH) mutations in gliomas through 1H magnetic resonance spectroscopy (MRS). It aims to identify the accumulation of D-2-hydroxyglutarate (2HG), a biomarker associated with IDH-mutated gliomas, which can aid in patient management and treatment decisions. The study will include patients with either probable or histologically confirmed low-grade gliomas, assessing their eligibility based on specific criteria. The trial is conducted at Hôpital Pitié Salpêtrière in Paris, France.
Who should consider this trial
Good fit: Ideal candidates include individuals with probable or confirmed grade II/III gliomas who are scheduled for surgery or have not received prior treatment.
Not a fit: Patients with contraindications to MRI or those with gliomas that do not exhibit IDH mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive method for diagnosing and monitoring gliomas, leading to improved patient outcomes.
How similar studies have performed: Other studies have shown promise in using MRS for detecting metabolic changes in gliomas, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Affiliation à un régime de sécurité sociale (bénéficiaire ou ayant droit) * Recueil du consentement écrit et éclairé * Une des deux situations suivantes : Groupe 1 : Probable gliome de grade II/III, dont l'exérèse est programmée Groupe 2 : gliome de grade II ou III prouvé histologiquement avec statut IDH1/IDH2 connu, n'ayant reçu aucun autre traitement que la chirurgie, et devant débuter un traitement autre que la chirurgie. * Présence d'un résidu tumoral évaluable (\>2 cm de diamètre en FLAIR) * Index de Karnofsky \> 60 * Contraception efficace pendant la durée de la recherche, complété par un test de grossesse négatif pour les femmes en âge de procréer. Exclusion Criteria: * Contrindications à l'IRM: pace maker ou stimulateur neuronal, corps étranger métallique intraoculaire ou intracérébral, implant cochléaire, valve cardiaque ou matériel artériel chirurgical métallique non compatible IRM, matériel métallique susceptible de concentrer les impulsions de radio fréquence, claustrophobie * femmes enceintes ou allaitantes * Critères réglementaires : Femme enceinte, parturiente, allaitante; Absence de signature du consentement ou refus du participant; Mesure de protection juridique (tutelle, curatelle, sauvegarde de justice); Participation à une autre recherche ne permettant pas de respecter la période; d'exclusion entre les 2 recherches; Personne ne bénéficiant pas d'un régime d'assurance maladie
Where this trial is running
Paris and 1 other locations
- Pitié-Salpetrière Hospital — Paris, France (Not_yet_recruiting)
- Hôpital Pitié Salpêtrière, 47 Boulevard de l'Hôpital, 75013 Paris — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Marc Sanson, MD, PhD — Paris Brain Institute, AP-HP, Paris, France
- Study coordinator: Marc Sanson, MD, PhD
- Email: marc.sanson@aphp.fr
- Phone: (0)1 42 16 03 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.