Whole-Brain Spectroscopy Guided Personalized Mapping of Transducer Arrays for Glioblastoma Patients Receiving Tumor Treating Fields
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Time to Progression
研究概览
简要总结
This research study is for Glioblastoma (GBM) patients who will be beginning Optune as part of their clinical care, which is a novel treatment that utilizes - tumor treating fields (TTFields), (aka, electrical therapy), which has shown to improve overall survival in large multi-center trials. As a part of this study, participants will either receive Optune with "standard array mapping" (based on regular contrast enhanced MRI) or an "alternative (more precise) array mapping" based on sophisticated state of the art MRI techniques including "whole brain spectroscopy". Whole brain MRI spectroscopy provides additional metabolic information to map out the full extent of tumor spreading within the brain (far beyond from what is seen on regular MRI), by identifying certain metabolites that are present in cancer cells versus healthy tissue. This study is being performed to show whether alternative array mapping improves treatment outcomes, as opposed to the standard array mapping, by maximizing delivery of TTFields dose, thereby achieving more effective tumor cell killing, decreasing the rate of local recurrence, and improving the overall survival as well as quality of life measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult population ≥ 22 years
- •Histologically confirmed diagnosis of GBM or molecular GBM according to c-IMPACT NOW criteria
- •Have undergone maximal safe surgical resection followed by either standard full course radiation of 6000 cGy in 6 weeks or a hypofractionated course of 4000 cGy in 3 weeks
- •3 Harboring any genotype profiles (MGMT promoter methylation or unmethylation and/or isocitrate dehydrogenase (IDH) mutant or IDH wild-type)
- •Possessing adequate hematological, hepatic and renal functions
- •Willingness to receive TTFields
排除标准
- •Presence of infra-tentorial GBM
- •Pregnancy
- •Significant co-morbidities at baseline which would prevent maintenance TMZ treatment
- •Active implanted medical device, a skull defect (such as missing bone with no replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators,pacemakers, defibrillators and programmable shunts. , other implanted electronic devices in the brain.
- •Sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.
- •Presence of significant hemorrhage in and around the tumor bed that may potentially degrade the image quality.
研究组 & 干预措施
Conventional Array Mapping Layout
Participants in this study arm will still receive Optune array layout mapping based on standard MR imaging sequences.
Advanced MR Imaging Array Mapping Layout
Participants in this study arm will receive Optune array layout mapping created from advanced MR imaging sequences obtained through trial enrollment.
干预措施: Whole Brain Spectroscopy Imaging Array Mapping Layout (Diagnostic Test)
结局指标
主要结局
Time to Progression
时间窗: 2 month intervals
Using whole brain spectroscopy imaging, diffusion and perfusion MR imaging, a combined multiparametric approach will be utilized to compare treatment response from patients enrolled in two study arms.
次要结局
- Overall Survival(through study completion and clinical follow ups for up to 5 years)