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

NCT06648473 | Withdrawn FDA Device

• 1 other identifier: PRO00116521
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Grade Glioma of Brain

Keywords

IDH1 Mutant; ivosidenib; Pro00116521; low grade glioma; MRI

Outcome Measures

Primary Outcomes (1)

• Repeatability

  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.

  1 year

Study Arms (1)

Magnetic Resonance Imaging (MRI) Scan

EXPERIMENTAL

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.

Diagnostic Test: MRI Scan

Interventions

MRI Scan 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.

Magnetic Resonance Imaging (MRI) Scan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Inability to have MRIs

Sponsors & Collaborators

• Duke University: lead
• Institut de Recherches Internationales Servier: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Links

• The Preston Robert Tisch Brain Tumor Center
• Duke Health Clinical Trials

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Katherine Peters, M.D.; Ph.D

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 18, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)