Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PETMR image
研究概览
简要总结
The primary goal of this project is to study the feasibility of a brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of human brains. The study will also allow us to compare the imaging performance of the investigator's brain-dedicated PET insert against a commercial whole-body permanently integrated PET/MRI system using a common radiopharmaceutical.
详细描述
This study will enroll up to 40 participants.
- 20 participants at Stanford injected with an FDA-approved PET tracer (e.g. amyloid, FDG, etc.), and
- 20 participants from Stanford who have been pre-injected with a radiopharmaceutical for a study on another PET imaging system
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Whole body radiation dose within the last year of less than 5000 mrem
- •Subjects intended for injected tracer studies (not associated with another study) must be willing/able to undergo injection of 6-12 mCi of either FDG or Neuraceq radiotracer. Both tracers are FDA approved
- •Subjects will be at least 21 years of age
- •Subject provides written informed consent
- •Subject is deemed healthy by the PI by via self-reported questionnaire
排除标准
- •For patients who will be receiving a tracer injection, no known allergy to the imaging agents
- •Participant has a history of or current diagnosis of cancer
- •Participant is pregnant or nursing
- •Metallic implants (contraindicated for MRI)
研究组 & 干预措施
Arm-1
20 participants will be recruited, inject with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.
干预措施: Injected radiotracer with PET Insert (Diagnostic Test)
Arm-2
20 participants will be recruited from other imaging studies that have been already injected (pre-injected) with a radiopharmaceutical. These subjects wont receive an additional injection of radiopharmaceutical.
干预措施: Pre-injected group with PET insert (Diagnostic Test)
结局指标
主要结局
PETMR image
时间窗: Up to 24 months
The key specific measurement is the resulting PET/MR image obtained from the single subject scan.
次要结局
未报告次要终点
研究者
Craig Levin
Professor, Radiology/ Nuclear Medicine
Stanford University