Clinical Application of Al18F-NOTA-FAPI-04 PET/CT or PET/MRI Imaging in Malignant Tumor,Cardiovascular or Immune Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Safety of Al18F-NOTA-FAPI
研究概览
简要总结
This prospective, single-center study investigates the biodistribution, dosimetry, safety, diagnostic performance of Al18F-NOTA-FAPI PET imaging in patients with malignant tumor,cardiovascular or immune disease. And evaluates the potential of Al18F-NOTA-FAPI PET imaging in Clinical treatment strategy guidance.
详细描述
FAP is expected to become an important indicator for predicting tumor prognosis, and also a new target for individualized treatment of various diseases such as tumors, rheumatoid arthritis, myocardial infarction, and thyroid-associated ophthalmopathy. The biological distribution of FAP in healthy adults is not yet clear. It is planned to obtain the normal PET/CT (or PET/MRI) images of healthy subjects after they use this tracer, in order to establish a benchmark for future application in patients.
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 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a. Age 18 years old or above, gender not restricted. b. Have undergone a health check-up within the last 3 months (at least completed chest X-ray / chest CT and abdominal B-ultrasound and other examinations), and no major diseases were found.
排除标准
- •As this study involves certain radiation exposure, patients who have had frequent radiation exposure due to clinical needs (those who have undergone a CT or PET/CT examination once within 3 months or 1 month respectively) are not included in the study.
研究组 & 干预措施
Al18F-NOTA-FAPI PET/CT(PET/MRI)
Evaluation of dosimetry, safety, diagnostic accuracy, and clinical treatment strategy guidance ability of Al18F-NOTA-FAPI PET/CT(or PET/MRI) in patients with malignant tumor,cardiovascular or immune disease.
干预措施: Al18F-NOTA-FAPI PET/CT(or PET/MRI) (Other)
结局指标
主要结局
Safety of Al18F-NOTA-FAPI
时间窗: From radiotracer injection to 24 hours post-injection.
Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.
Diagnostic accuracy of Al18F-NOTA-FAPI PET/CT(PET/MRI) for cardiovascular or immune disease.
时间窗: Through study completion, 1-1.5 years .
SUVmax 、SUVmean and T2 value（MRI）of the heart and the eye muscles will be measured. Two nuclear medicine physicians will independently review the images, and a third physician will adjudicate in case of disagreement to reach a final diagnosis. Surgical pathology results or Long term follow up findings will serve as the reference standard to determine the sensitivity and specificity .
次要结局
- SUVmax of normal organs(From study completion to 6 months after completion.)
- Absorbed dose of target organs(From study completion to 6 months after completion)