NCT06648473

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Low Grade Glioma of Brain

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-10-18
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study