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

Not Applicable

Not yet recruiting

• Conditions: Low Grade Glioma of Brain

• Registration Number: NCT06648473
• Lead Sponsor: Duke University

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

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-18
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Study Start: 2025-04-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Repeatability	1 year	Bland-Altman repeatability will be measured to create a repeat dataset test bed for the evaluation of current and new software for the ability to consistently measure change in the volume of tumor-related T2/Fluid Attenuated Inversion Recovery (FLAIR) abnormality.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States