Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Repeatability
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •1. Inability to have MRIs
研究组 & 干预措施
Magnetic Resonance Imaging (MRI) Scan
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.
干预措施: MRI Scan (Diagnostic Test)
结局指标
主要结局
Repeatability
时间窗: 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.
次要结局
未报告次要终点