Low Grade Glioma of Brain
Conditions
Keywords
IDH1 Mutant, ivosidenib, Pro00116521, low grade glioma, MRI
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
Interventions
DIAGNOSTIC_TESTMRI 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.
Sponsors
Duke University
Institut de Recherches Internationales Servier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatherine Peters, M.D.; Ph.D
Duke University
Outcome results
None listed