Study of Novel PET Tracer Gallium [68Ga]/ Fluorine [18F] -FAPI-04 in the Diagnosis of Cardiovascular Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety and Tolerability Profile Measured by Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety of fibroblast activating protein receptor imaging agent [68Ga]/ Fluorine [18F] -fibroblast activating protein inhibitor (68Ga/18F-FAPI-04) in clinical application and to verify its effectiveness in the diagnosis of cardiovascular diseases.
详细描述
The implementation of this project will promote the research of PET-MRI molecular imaging using the new nuclide imaging with the target of FAP combined with the MRI T1 mapping and ECV measurement technology, realize the fusion of nuclear medicine and magnetic resonance technology in a real sense, dynamically monitor the occurrence and development of myocardial fibrosis in heart failure at an early stage, and establish a complete set of myocardial fibrosis imaging programs. To provide an important basis for the exploration of anti-fibrosis therapy in heart failure and accelerate the pace of clinical transformation of this protocol.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary subjects, patients or their legal representatives to sign informed consent;
- •There was no limitation on the gender of the volunteers, whose age ranged from 18 to 85 years old, including the cut-off value;
- •Myocardial injury caused by various causes was found by other imaging methods (cardiac ultrasound, coronary angiography, coronary CT, cardiac MRI, etc.);
- •Kidney GFR > 50 ml/min, ERPF > 280 ml/min, platelet count (PLT) > 75 000/μL, leukocyte (WBC) > 3000/μL, alanine aminotransferase ALT, aspartate aminotransferase AST < 3 times the normal value.
排除标准
- •Allergic to the same drugs (drugs with similar chemical or biological components to fibroblast activating protein inhibitors), allergic constitution or currently suffering from allergic diseases;
- •Clinical investigators who are currently conducting clinical studies on other drugs, or who have participated in any drug (excluding vitamins and minerals);
- •Have other clinical problems that are difficult to control (such as HIV, hepatitis C virus infection or active hepatitis B, or other severe chronic infections and serious mental, neurological, respiratory and other diseases);
- •Red blood cell RBC is less than 4×1012, white blood cell WBC is less than 3×109, hemoglobin is less than 80g/L, PLT is less than 75,000 ×109;
- •Significantly abnormal liver and kidney function, GFR less than 20 ml/min;
- •Cardiac ejection fraction (EF) was assessed to be less than 10%;
- •The expected survival time is less than half a year; Coronary stent implantation within 2 weeks or coronary artery bypass graft within 6 months;
- •Severe acute concomitant disease or severe refractory mental disorder;
- •Pregnant and lactating women (pregnancy is defined as positive in blood pregnancy studies);
- •Patients whose physical conditions are not suitable for radioactive examination;
- •Patients with metal implants (pacemakers, etc.) or spatial claustrophobia or other MRI related contraindications;
- •Any situation that the presiding officer of this study believes may cause harm or potential harm to any link related to this test.
研究组 & 干预措施
68Ga/18F-FAPI-04
For the injection, subjects will receive a target dose of 0.1~0.15mCi/Kg 68Ga/18F-FAPI-04 as a bolus injection.
干预措施: 68Ga/18F-FAPI-04 (Drug)
结局指标
主要结局
Safety and Tolerability Profile Measured by Adverse Events (AEs)
时间窗: 31 months
Safety and tolerability profile for the administration of 68Ga/18F-FAPI-04 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs).
Assessment of 68Ga/18F-FAPI-04 Uptake Patterns by Regional SUV Values
时间窗: 31 months
68Ga/18F-FAPI-04 uptake patterns will be assessed in regions of interest (ROIs) which relevant to myocardial fibrosis pathology. Standard uptake value (SUV) will be calculated for each ROI, and standardized uptake value ratios (SUVRs) will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region.
次要结局
未报告次要终点
研究者
FengWang
Director of nuclear medicine department
Nanjing First Hospital, Nanjing Medical University