Clinical trial · Interventional
Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib
NCT06648473CI-TRIAL-00101793withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): sponsor withdrew funding
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Grade Glioma of Brain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI Scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Magnetic Resonance Imaging (MRI) Scan
- description
- 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.
- interventionNames
- Diagnostic Test: MRI Scan
Primary outcomes (1)
- measure
- Repeatability
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.