Pilot Study of Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Evaluate y90-PET/MRI and PET/CT for potential on reporting presence of extrahepatic deposition of microspheres
研究概览
简要总结
The successful localization of the y90 microspheres by PET/MR and/or PET/CT scans would be a useful tool in individualizing patient care after the radioembolization procedure. The information from a PET/MR or PET/CT scan would allow for early evaluation of the technical success of the procedure.
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
- •Participant must successfully complete the MRI screening form if receiving an MRI
- •Participant must be scheduled to undergo radioembolization for any indication
- •Participant must be ≥ 18 years of age
- •Participant must be able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document
排除标准
- •Participant must not have any contraindications to MRI scanning
- •Patient must not be pregnant or breastfeeding
- •If agreeing to MRI contrast, participant must not have renal insufficiency (glomerular filtration rate (GFR < 30 mL/min/1.73 m2) measured within the past 60 days
- •If agreeing to MRI contrast, participant must not be on dialysis
- •If agreeing to MRI contrast, participant must not have had a prior allergic reaction to gadolinium-based contrast agents
- •PET/MRI or PET/CT is not able to be scheduled within 72 hours of radioembolization
研究组 & 干预措施
PET/MR or PET/CT
- Patients must have had radioembolization, within 72 hours of the PET/MR or PET/CT
- Subjects will be asked to lie still within the scanner for up to 1.5 hours while images are acquired for the liver
干预措施: PET/MR (Device)
PET/MR or PET/CT
- Patients must have had radioembolization, within 72 hours of the PET/MR or PET/CT
- Subjects will be asked to lie still within the scanner for up to 1.5 hours while images are acquired for the liver
干预措施: PET/CT (Device)
结局指标
主要结局
Evaluate y90-PET/MRI and PET/CT for potential on reporting presence of extrahepatic deposition of microspheres
时间窗: 1 day (one time event for patient)
A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine any presence of extrahepatic deposition of microspheres.
Evaluate y90-PET/MRI and PET/CT for potential on reporting technical success of radioembolization
时间窗: 1 day (one time event for patient)
A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine whether technical success of the procedure can be determined. They will rate the images if they are 'adequate' to report on these two measures.
次要结局
未报告次要终点