Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-03-06
2028-03-02
Brief Summary
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Mutations in the genes encoding isocitrate dehydrogenase (IDH) are found in about 80% of low-grade gliomas and are associated with a favorable prognosis. Remarkably, IDH-mutated gliomas are characterized by a specific cellular metabolism causing the accumulation of D-2-hydroxyglutarate (2HG) in tumor cells. 2HG can be detected in vivo using 1H magnetic resonance spectroscopy (MRS) and is recognized as a unique, noninvasive biomarker of IDH-mutated gliomas. Noninvasive detection of IDH mutations via 2HG MRS represents a crucial step for decision-making and patient care.
A subset of IDH-mutated tumors also presents a complete deletion of 1p and 19q chromosome arms (1p/19q codeletion). The 1p/19q codeletion is specifically linked to the oligodendroglial histologic subtype and it has been associated with a better patient outcome. However, the biological effects of this genetic alteration are still unclear and in vivo markers are lacking. Recently, we reported the first in vivo detection of the cystathionine molecule in human brain gliomas using MRS and explored the association between cystathionine accumulation and 1p/19q codeletion in gliomas.
In this project, the investigation team will combine cutting edge MRI and MRS techniques for metabolic and microstructural characterization of brain tumors with the aim of providing novel reliable noninvasive biomarkers of tumor genetic subtypes. These methods will enable noninvasive identification of IDH-mutated gliomas and, potentially, 1p/19q codeleted gliomas. In addition, the researchers will investigate the utility of 2HG, cystathionine and MRI microstructural markers to monitor tumor response to anti-cancer treatments and tumor progression.
The outputs of this project, altogether, may open new avenues to a better understanding of the pathophysiological mechanisms of oncogenesis and the design of new treatments for gliomas.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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MRI examination
MRI
MRI without contrast agent
Interventions
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MRI
MRI without contrast agent
Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Francesca Branzoli, PhD
Role: STUDY_DIRECTOR
Paris Brain Institute, Paris, France
Marc Sanson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Paris Brain Institute, AP-HP, Paris, France
Locations
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Pitié-Salpetrière Hospital
Paris, , France
Hôpital Pitié Salpêtrière, 47 Boulevard de l'Hôpital, 75013 Paris
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A03015-36
Identifier Type: OTHER
Identifier Source: secondary_id
C21-27
Identifier Type: -
Identifier Source: org_study_id
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