Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in oxygen-weighted SAGE-EPI to measure oxygen extraction (R2') before and after oxygen enrichment
研究概览
简要总结
This trial looks to study the safety and feasibility of using oxygen-enhanced molecular MRI to understand how cancer cells use oxygen differently than normal cells. Cancer cells tend to utilize (or not utilize) oxygen differently than normal cells. By using the oxygen-enhanced molecular MRI, researchers will be able to create spatial "maps" depicting areas of abnormal oxygen utilization unique to cancer. This type of information may be useful for diagnosing new cancers, understanding various "subtypes" of cancer that might utilize oxygen differently, or this information may be useful for evaluating new drugs that impact cancer metabolism.
详细描述
PRIMARY OBJECTIVES:
I. Determine the safety, feasibility, and sensitivity of oxygen-enhanced molecular magnetic resonance imaging (MRI) in healthy volunteers.
II. Measure oxygen-enhanced molecular MRI characteristics in human brain tumors.
OUTLINE:
Participants undergo arterial spin labeling (ASL) MRI scan and amine chemical exchange saturation transfer spin-and-gradient echo echo-planar imaging using amine proton CEST echo spin-and-gradient echo (SAGE) EPI (CEST-SAGE-EPI) while breathing normal room air (21% oxygen). Patients then undergo another ASL MRI and CEST-SAGE-EPI while breathing medical grade air (100% oxygen). Total ASL MRI and CEST-SAGE-EPI imaging scan time is 60 minutes.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers will include persons who at the time of scans do not present with known neurological conditions that might impact tissue imaging results
- •Patient participants should have suspected or pathology-confirmed diagnosis of a brain tumor (any histological subtype including brain metastases)
- •All participants must be able to obtain an MRI scan and must be able to safely breathe high concentrations of oxygen
排除标准
- •Participants with contraindications to MRI including metal implants
- •Participants who are deemed not able to or not safe to breath high concentrations of oxygen
结局指标
主要结局
Change in oxygen-weighted SAGE-EPI to measure oxygen extraction (R2') before and after oxygen enrichment
时间窗: Baseline and two hours after Oxygen enrichment
We will perform voxel-wise t-tests via AFNI software between the average R2' and MTRasym during normal room air and medical grade air.
Change in pH-weighted amine CEST MRI to measure tumor acidity (MTRasym at 3ppm) before/after oxygen enrichment
时间窗: Baseline and two hours after Oxygen enrichment
Will be measured by voxel-wise t-tests via analysis of functional NeuroImages (AFNI) software between the average R2' and MTRasym during normal room air and medical grade air.
Tumor blood flow as measured by cerebral blood flow (CBF) from arterial spin labeling (ASL).
时间窗: Baseline and two hours after Oxygen enrichment
Change in ASL perfusion estimates of relative cerebral blood flow (CBF) before and after oxygen enrichment
次要结局
未报告次要终点