Comparison of Whole Body DWI to FDG PET Using PET/MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of lesions characterized as positive
研究概览
简要总结
This is a single arm prospective trial that evaluates whole body diffusion weight imaging (DWI) compared to 18F-fludeoxyglucose (FDG) Positron Emission Tomography with Magnetic resonance imaging (PET/MRI) in participants with known metastatic cancer.
详细描述
PRIMARY OBJECTIVE:
I. Correlation of DWI and FDG to detect disease.
SECONDARY OBJECTIVE:
I. Inter-reader variability of DWI interpretation by region.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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.
- •Non FDG PET imaging study scheduled to be performed within 60 days (before or after) of the research PET/MRI.
- •Ability to understand a written informed consent document, and the willingness to sign it.
- •Diagnosis of metastatic cancer.
排除标准
- •Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- •Individuals with contraindications to MRI. This will be determined through review of the UCSF MRI screening form by qualified site personnel
研究组 & 干预措施
Whole Body DWI plus FDG PET/MRI
Participants will receive 5 to 10 Megabecquerel (MBq) +/- 10% of 18F-fluorodeoxyglucose as an intravenous injection and undergo a FDG PET/MRI scan that will extend from the vertex to the mid-thighs. Imaging will be performed from vertex to mid-thighs using standard protocol. Participants may also obtain an optional second FDG PET/MRI with DWI within 6 months.
干预措施: Fluorodeoxyglucose F18 (Drug)
Whole Body DWI plus FDG PET/MRI
Participants will receive 5 to 10 Megabecquerel (MBq) +/- 10% of 18F-fluorodeoxyglucose as an intravenous injection and undergo a FDG PET/MRI scan that will extend from the vertex to the mid-thighs. Imaging will be performed from vertex to mid-thighs using standard protocol. Participants may also obtain an optional second FDG PET/MRI with DWI within 6 months.
干预措施: Positron Emission Tomography combined with Magnetic resonance imaging (PET/MRI) (Procedure)
Whole Body DWI plus FDG PET/MRI
Participants will receive 5 to 10 Megabecquerel (MBq) +/- 10% of 18F-fluorodeoxyglucose as an intravenous injection and undergo a FDG PET/MRI scan that will extend from the vertex to the mid-thighs. Imaging will be performed from vertex to mid-thighs using standard protocol. Participants may also obtain an optional second FDG PET/MRI with DWI within 6 months.
干预措施: General Electric (GE) SIGNA PET/MR (Device)
Whole Body DWI plus FDG PET/MRI
Participants will receive 5 to 10 Megabecquerel (MBq) +/- 10% of 18F-fluorodeoxyglucose as an intravenous injection and undergo a FDG PET/MRI scan that will extend from the vertex to the mid-thighs. Imaging will be performed from vertex to mid-thighs using standard protocol. Participants may also obtain an optional second FDG PET/MRI with DWI within 6 months.
干预措施: Whole Body Magnetic Resonance Imaging with Diffusion-Weighted Imaging (WB-MRI-DWI) (Procedure)
结局指标
主要结局
Proportion of lesions characterized as positive
时间窗: Up to 6 months
The overall proportion of lesions that will be characterized as positive on whole body (WB) diffusion weight imaging (DWI) and FDG PET.
次要结局
- Inter-reader variability of diffusion weight imaging (DWI) interpretation(Up to 6 months)