Development of a Clinical CEST MR Fingerprinting Method for Treatment Response Assessment in Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Change of Rapid chemical exchange saturation transfer (CEST) imaging with magnetic resonance fingerprinting (MRF)/CEST-MRF parameters with and without motion
研究概览
简要总结
The purpose of this study is to develop and test a new magnetic resonance imaging (MRI) technique to see if it can be used to tell the difference between tumor growth from worsening of cancer and growth from the effects of treatment in participants who have brain tumors treated with radiation therapy called stereotactic radiosurgery (SRS).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers [for Study Aim 1 (SA1) and Study Aim 2 (SA2)] will be entered into the study if they meet the following criteria:
- •Age ≥ 18 years
- •Able to understand and give informed consent
- •No known cancer diagnosis
- •Patients [for Study Aim 1 (SA1)] will be entered into the study if they meet the following criteria:
- •Age ≥ 18 years
- •Able to understand and give informed consent
- •At least one untreated brain metastasis > 1cm (e.g., an enhancing lesion in the brain of a patient with known systemic cancer determined likely to represent metastasis by neuroradiologist)
- •Patients [for Study Aim 3 (SA3)] will be entered into the study if they meet the following criteria:
- •Age ≥ 18 years
- •Able to understand and give informed consent
- •At least one untreated brain metastasis > 1cm (e.g., an enhancing lesion in the brain of a patient with known systemic cancer determined likely to represent metastasis by neuroradiologist)
- •Planned SRS treatment
排除标准
- •Healthy volunteers (SA1 & SA2) and patients (SA1 & SA3) exclusion criteria:
- •Pregnant or breastfeeding women
- •Pre-existing medical conditions, including the likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
- •Age < 18 years
研究组 & 干预措施
Participants with Brain Metastases
Participants will have at least one untreated brain metastasis > 1cm
干预措施: CEST-MRF (Diagnostic Test)
Healthy participants
Participants will have no known cancer diagnosis. Volunteers enrolled on this protocol may undergo multiple MRI examinations periodically for studies of reproducibility.
干预措施: CEST-MRF (Diagnostic Test)
结局指标
主要结局
Change of Rapid chemical exchange saturation transfer (CEST) imaging with magnetic resonance fingerprinting (MRF)/CEST-MRF parameters with and without motion
时间窗: Up to 3 years
Develop a rapid and robust 3D CEST-MRF pulse sequence for clinical scanners using our preclinical CEST-MRF pulse sequence as a basis by evaluating the changes of the 6 CEST-MRF parameters with and without motion. These parameters include the water T1 and T2 relaxation (T1w,T2w), amide exchange rate (ksw) and volume fraction (fs) and the semi-solid exchange rate (kssw) and volume fraction (fss).
次要结局
- Create CEST-MRF parameter maps(Up to 3 years)
- Measure longitudinal changes in CEST-MRF after SRS(Up to 3 years)