A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of BFPET as a Potential Myocardial Perfusion Imaging (MPI) Agent for PET
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in blood pressure. Safety Biodistribution Radiation dosimetry
研究概览
简要总结
Safety and dosimetry of BFPET™ will be evaluated in healthy volunteers and Coronary Artery Disease (CAD) patients , male or female and of age ranging between 20-80 years old.
详细描述
Study Procedures:
Visit 1: Screening - Eligibility determination
Visit 2 (within 14 days post screening): Injection of BFPET™ and PET Imaging
Visit 3 (within 24-48 hours post dose): Follow-up Visit
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must provide written informed consent prior to any study related procedures;
- •Subjects must be ≥ 20 and ≤ 80 years of age;
- •Subjects must have history of CAD documented by an abnormal stress myocardial perfusion imaging (MPI) study and cardiac catheterization within 6 months of the BFPET studyExclusion Criteria
排除标准
- •Subject has a Positive (+) Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing;
- •Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
- •Coronary artery bypass graft (CABG) within 6 months;
- •Percutaneous coronary intervention (PCI), with stent placement within six months;
- •Blood pressure over 180/100;
- •Acute changes in ECG;
- •Recent (within 3 months) cardiac arrest, unstable angina, myocardial infarction, cerebro-vascular accident (CVA), any general anesthesia procedure, any surgical procedures;
- •Any implanted pacemaker or defibrillator use within the last three months;
- •Inability to remain in camera for approximately 60 minutes (Smokers and COPD are included as long as they can breath in PET camera and not taking O2 through nasal canula);
- •History of Diabetes Mellitus;
- •Serum creatinine > 2 mg/dL;
- •All cancer patients;
- •Body Mass Index (BMI) is over 35;
- •Any exposure to any investigational drugs or medical device within four (4) weeks prior to imaging study;
- •Any exposure to radiopharmaceuticals within four (4) weeks prior to the date of imaging study;
研究组 & 干预措施
BF-PET
干预措施: BFPET (Drug)
结局指标
主要结局
Change in blood pressure. Safety Biodistribution Radiation dosimetry
时间窗: pre-dose, post-dose 0, 1, 5, 15, 30, 60 and 90 minutes, 2 hours, 24-48 hours post-dose and 7 days post-dose.
Change in vital signs, physical examination, ECG measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose. Change in 12-lead Electrocardiogram measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose. Change in 24-hour Holter (initiated 2 hours pre-dose, continuous for 24 hours, time stop recorded. Change in dosimetry sampling (blood and urine)blood measured at time 0 (immediately following injection), 1,5, 15, 30, 60, 90 minutes. Adverse event assessment immediate post dose, 24-48 hours and 7 days post-dose.
次要结局
- Performance characteristics of BFPET as a PET tracer for myocardial imaging.(30, 60, 120, and 240 seconds.)