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Trial Title:
Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib
NCT ID:
NCT06648473
Condition:
Low Grade Glioma of Brain
Conditions: Official terms:
Glioma
Conditions: Keywords:
IDH1 Mutant
ivosidenib
Pro00116521
low grade glioma
MRI
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
MRI Scan
Description:
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.
Arm group label:
Magnetic Resonance Imaging (MRI) Scan
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Contact:
Last name:
Katherine Peters, M.D.; Ph.D.
Phone:
919-684-5301
Email:
dukebrain1@dm.duke.edu
Contact backup:
Last name:
Stevie Threatt
Phone:
919-684-5301
Email:
dukebrain1@dm.duke.edu
Start date:
December 1, 2024
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
Institut de Recherches Internationales Servier
Agency class:
Other
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06648473
https://tischbraintumorcenter.duke.edu/
https://www.dukehealth.org/clinical-trials
