Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648473
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None