Assessment of Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas and Tumor Region-Specific Biomarker Correlation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Incidence of Patient Complications Following Tumor Resection
研究概览
简要总结
This study evaluates the use of specialized magnetic resonance imaging (MRI) techniques including magnetic resonance (MR) perfusion and 2-hydroxyglutarate (2HG) spectroscopy in the surgical treatment of gliomas.
Cohort 1 participants will undergo an MR perfusion scan or 2-HG spectroscopy prior to surgery and intra-operatively.
Cohort 2 participants will only undergo standard of care imaging and tumor acquisition. Participant participation will end at the completion of surgery and will be transitioned to standard of care follow-up.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Suspected glioma (grade II, III, or IV)
- •Preoperative MR perfusion (enhancing tumors)
- •Preoperative MR 2-HG spectroscopy (nonenhancing tumors)
- •Patient indicated for surgical resection, standard radiation, and standard chemotherapy as a standard of care
- •Karnofsky performance status ≥ 60
- •Life expectancy > 12 weeks
- •Cohort 1: Ability to comply with study and follow-up procedures
- •Cohort 2: Ability to comply with study procedures
排除标准
- •Prior diagnosis of intracranial glioma
- •Other malignancy with expected need for systemic therapy within 3 years
- •Inability to have 6000 grays of radiation to the brain
- •Need for urgent palliative intervention for primary disease (e.g., impending herniation)
- •Evidence of bleeding diathesis or coagulopathy
- •History of intracerebral abscess within 6 months prior to Day 0
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- •Pregnant females
- •Subjects unable to undergo an MRI with contrast
研究组 & 干预措施
Cohort 1, Group A (contrast enhancing tumor)
Group A patients will undergo standard tumor preoperative imaging and MR perfusion scan prior to surgical resection. Group A patients will undergo standard intraoperative imaging along with MR perfusion scan during surgical resection.
干预措施: MR Perfusion Scan (Device)
Cohort 1, Group B (non-enhancing tumor)
Group B patients will undergo standard tumor preoperative imaging and 2HG spectroscopy scan prior to surgical resection. Group A patients will undergo standard intraoperative imaging along with 2HG spectroscopy scan during surgical resection.
干预措施: 2HG Spectroscopy Scan (Device)
Cohort 2
During the analysis for cohort 1, we found significant differences in the pre MRI samples and the post intraoperative MRI samples. Cohort 2, which will include 10 additional patients, has be created to confirm these differences. Unlike cohort 1, advanced imaging (2-HG spectroscopy and MR perfusion) is not needed to make this comparison. The standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples. The specific aim of Cohort 2 is:
1. Compare areas from initial surgery with that of extended resection after intraoperative SOC MRI in 10 additional subjects (Cohort 2).
干预措施: Standard of Care Intraoperative MRI (Device)
结局指标
主要结局
Incidence of Patient Complications Following Tumor Resection
时间窗: 1 year
Any surgical complications at post-op, hospital discharge, 1-month, 3-months, 6-months, and 1 year following surgery using the Common Terminology Criteria for Adverse Events (CTCAE)
Intraoperative Imaging Completion
时间窗: 1 day
This is a feasibility study to see whether advanced imaging modalities can be used intraoperatively so the primary outcome is a yes/no regarding completion of imaging.
次要结局
未报告次要终点