Assessment Of A Novel Metabolic Imaging Modalities As A Predictor Of Therapeutic Efficacy In Glioblastoma (GBM)
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The goal of this study is to evaluate the prognostic capacity of DMI in a trial assessing the efficacy of adding BPM31510, a lipid nano dispersion of CoQ10 to standard treatment of Glioblastoma (GBM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any participant that consents to entry into the Phase II BPM31510 parent study (BPM31510IV-11)
- •Women of childbearing potential must have a negative pregnancy test
- •Ability to understand and the willingness to provide written informed consent.
排除标准
- •Refuse to have an IV
- •Allergy to MRI contrasts
- •Diabetic patients who are taking insulin
研究组 & 干预措施
Deuterated Glucose + MRI
Participants will receive [6,6-²H₂]-glucose orally at a dose of 0.75g per kg of body weight (maximum 60g), dissolved in 200-500mL of water. Approximately 45 minutes after ingestion, participants will undergo an MRI scan consisting of a 30-minute conventional MRI brain study followed by a 1-hour Deuterium Metabolic Imaging (DMI) study. A Gadolinium contrast agent may be administered if more than 4 weeks have passed since the last enhanced MRI scan.
干预措施: [6,6-²H₂]-Glucose (Other)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: up to 36 months
Progression-Free Survival (PFS) is defined as the time from the start of treatment until disease progression or death from any cause, whichever occurs first
Overall Survival (OS)
时间窗: up to 36 months
Overall Survival (OS) is defined as the time from randomization until death from any cause.
次要结局
未报告次要终点