Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-12-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Low Grade Glioma of Brain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Magnetic Resonance Imaging (MRI) Scan

Subjects will begin the MRI with T1-pre, T2w, and volumetric 3D Fluid Attenuated Inversion Recovery (FLAIR) images being obtained. The subject will be brought out of the MRI magnet and moved into a seated position and will then have a standard Brain Tumor Imaging Protocol MRI scan.

Group Type EXPERIMENTAL

MRI Scan

Intervention Type DIAGNOSTIC_TEST

Subjects will begin the MRI with T1-pre, T2w, and volumetric 3D FLAIR images being obtained. The subject will be brought out of the MRI magnet and moved into a seated position and will then have a standard Brain Tumor Imaging Protocol MRI scan.

Interventions

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MRI Scan

Subjects will begin the MRI with T1-pre, T2w, and volumetric 3D FLAIR images being obtained. The subject will be brought out of the MRI magnet and moved into a seated position and will then have a standard Brain Tumor Imaging Protocol MRI scan.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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