Clinical trial NCT06648473: Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib
Official title: Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Grade Glioma of Brain
Keywords: IDH1 Mutant
ivosidenib
Pro00116521
low grade glioma
MRI
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Institut de Recherches Internationales Servier
First posted: 2024-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the repeatability of magnetic resonance imaging (MRI) in patients with isocitrate dehydrogenase 1 (IDH1) mutant (mIDH1) low-grade diffuse glioma \[World Health Organization (WHO) grade 2\] who are receiving off-label ivosidenib.

Detailed description: 40 adult patients with histologically low-grade mIDH1 glioma (WHO grade 2) who are being seen at Duke Preston Robert Tisch Brain Tumor Center (PRTBTC) for treatment or evaluations, will be included in this protocol. Patients included in this protocol must currently be receiving off-label ivosidenib per recommendation of their treating physician and must be scheduled to receive a routine contrast-enhanced brain Magnetic Resonance Imaging (MRI) scan as part of their clinical care. The images from the routine MRI scan will be obtained as part of the patient's clinical care and will only be used in this research study if the patient agrees to be on-study by signing the informed consent form (ICF).

Subjects will undergo a routine Brain Tumor Imaging Protocol MRI scan with additional imaging sequences, in order to create a database of short interval "coffee break" repeat MRI sets. Subjects will begin their MRI by having T1-pre, T2w, and volumetric 3D Fluid Attenuated Inversion Recovery (FLAIR) images. The subject will be brought out of the magnet, sat up and then have the standard Brain Tumor Imaging Protocol MRI scan performed.

Subjects will remain on this study for the one day during which they are scheduled to receive their MRI scan

Eligibility criteria: Inclusion Criteria:

1. Written informed consent prior to beginning specific protocol procedures
2. Scheduled for contrast-enhanced magnetic resonance imaging (MRI) as part of clinical care
3. Histologically IDH1 mutant low-grade glioma (WHO grade 2) and actively receiving ivosidenib
4. Active patient treatment or evaluations at the Preston Robert Tisch Brain Tumor Center at Duke
5. Age ≥18 years and ≤70 years
6. Karnofsky performance index ≥70%
7. Primary treating physician approval

Exclusion Criteria:

1. Inability to have MRIs

Primary outcomes:
measure: Repeatability
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Katherine Peters, M.D.; Ph.D
role: PRINCIPAL_INVESTIGATOR
References: