Spectroscopic MRI Guided Proton Therapy for Pediatric High-Grade Glioma (RAD4500)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This trial studies how well spectroscopic magnetic resonance imaging (MRI) guided proton therapy works in assessing metabolic change in pediatric patients with brain tumors. The non-invasive imaging, such as spectroscopic MRI may help to map the differences in tumor metabolism compared to healthy tissue without injection of any contrast agent.
详细描述
PRIMARY OBJECTIVES:
I. To obtain spectroscopic (s)MRI data from pediatric high grade glioma (HGG) patients before receiving standard of care radiation therapy (RT) and correlate baseline Cho/NAA ratios to recurrence patterns. (Cohort 1, observational) II. To assess the feasibility and safety of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery. (Cohort 2, intervention)
SECONDARY OBJECTIVES:
I. To evaluate how Cho/NAA defined radiation target volumes compare to standard of care radiation target volumes in size and resulting radiation delivery to adjacent normal tissue, by creating mock comparison RT plans for each patient.
II. To compare voxel-to-voxel changes in pre-treatment and post-treatment sMRI and evaluate as potential early predictor of tumor response/recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed high-grade glioma (World Health Organization [WHO] grade 3-4). Patients with a radiographically diagnosed high-grade glioma may enroll prior to pathologic confirmation, but would be removed from study if pathology did not confirm the diagnosis of high-grade glioma.
- •Primary tumor located within the supratentorial brain.
- •Recommended to receive definitive radiation therapy.
- •Able to receive MRI scans.
- •Both males and females, and members of all races and ethnic groups are eligible for this trial.
排除标准
- •Patients with pacemakers, non-titanium aneurysm clips, neurostimulators, cochlear implants, non-titanium metal in ocular structures, or other incompatible implants which makes MRI safety an issue are excluded.
- •Patients that have any significant medical illnesses that in the investigator's opinion cannot be adequately tolerate MRI scan are excluded.
- •Pathology demonstrated low-grade glioma or other benign or non-invasive brain tumor.
研究组 & 干预措施
Group 2
Patients will undergo 3-4 sMRI scans at baseline prior to RT, 1 month, 4 months, and 7 months after RT, and/or at any time of suspected tumor recurrence.
干预措施: Proton Therapy (Device)
Diagnostic (sMRI)
Patients undergo sMRI over less than 1 hour within 7 days prior to start of standard of care radiation therapy and at 10 weeks.
干预措施: Magnetic Resonance Spectroscopic Imaging (Procedure)
Diagnostic (sMRI)
Patients undergo sMRI over less than 1 hour within 7 days prior to start of standard of care radiation therapy and at 10 weeks.
干预措施: Proton Therapy (Device)
Group 2
Patients will undergo 3-4 sMRI scans at baseline prior to RT, 1 month, 4 months, and 7 months after RT, and/or at any time of suspected tumor recurrence.
干预措施: Magnetic Resonance Spectroscopic Imaging (Procedure)
结局指标
主要结局
Incidence of adverse events
时间窗: Through study completion, an average of 1 year
Toxicity will be defined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy
时间窗: Through study completion, an average of 1 year
The spatial relationship between baseline sMRI abnormalities and tumor recurrence will be reported and proportion of overlap will be quantified.
Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery
时间窗: From Baseline up to 3 years from treatment
Will be estimated by the Kaplan-Meier Method.
次要结局
未报告次要终点
研究者
Bree Eaton
Principal Investigator
Emory University