A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- measure radiotracer avidity
研究概览
简要总结
The purpose of this research study is to test new ways to improve the usefulness of the world's first total-body positron emission tomography (PET)/computed tomography (CT) scanner (EXPLORER) by collecting data from PET scans using one of three different imaging agents: 18F-PSMA; 18F-FES; or, 68Ga DOTATATE. These imaging agents are approved by the FDA to be used for patients diagnosed with prostate cancer (18F-PSMA), neuroendocrine tumor (68Ga DOTATATE), or breast cancer (18F-FES).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •18F-PSMA (n=3) and 68Ga-PSMA (n=3)
- •Inclusion criteria:
- •Persons >18 yo with suspected prostate cancer metastasis
- •Prior imaging study (CT, and/or MRI and/or Bone scan and/or Fluciclovine scan) suspicious for metastatic disease, obtained within 4 months from the research scan date.
- •68Ga DOTATATE (n=3) or 64Cu-DOTATATE (n=3)
- •Inclusion Criteria:
- •Persons > 18 yo suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors (NETs)
- •Prior DOTATATE PET/CT scan suspicious for tumor obtained not earlier than 4 months from the research scan date.
排除标准
- •Recent administration of long-acting somatostatin analogs
- •Exclusion Criteria for all participants:
- •Adults unable to consent
- •Pregnant/lactating persons
- •Prisoners
- •Unable to lie supine for up to 90 minutes at different timepoints in the PET scanner
- •Uncontrolled claustrophobia
- •Any significant medical condition that in the opinion of the investigator would prevent the participant from participating and/or adhering to study related procedures or interfere with participant safety
研究组 & 干预措施
Total-body PET scan
All participants will receive a dynamic PET scan for up to 90 minutes. This will be followed by two 30 minutes static PET scans at 3 hours +/-20 minutes and 6 hours +/-20 minutes post injection. Subjects injected with 18F-PSMA or 18F-FES will receive a 40 minute scan at 9 hours +/-20 minutes post injection.
干预措施: Total-body PET imaging (Diagnostic Test)
结局指标
主要结局
measure radiotracer avidity
时间窗: One study imaging visit lasting up to 10 hours
measure radiotracer avidity, i.e. standardized uptake value measurements (SUV max and mean) of tumor and normal tissue as a function of time with 18F-PSMA, 18F-FES, 68Ga DOTATATE in a total-body PET scanner among men with suspected prostate cancer metastasis, patients suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors, and patients with recurrent or metastatic breast cancer.
次要结局
未报告次要终点