NCT02252783Unknown2 期
A Phase II Open-Labeled Study to Evaluate BFPET as a Myocardial Perfusion Imaging Agent for the Evaluation of Coronary Artery Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of BFPET
研究概览
简要总结
BFPET will be evaluated as a diagnostic PET agent for assessing myocardial perfusion in subjects with known or suspected coronary artery disease (CAD) as compared to standard nuclear myocardial perfusion imaging (MPI). The safety of BFPET will be evaluated in known or suspected CAD subjects.
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must provide written informed consent prior to any study related procedures;
- •Subjects must be ≥ 21 and ≤ 85 years of age;
- •Subjects must have known or suspected CAD documented by ≥2 segments of reversible perfusion abnormalities on a SPECT (MPI)study
- •Exclusion Criteria
- •Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
- •Blood pressure over 180/100mmHg
- •Acute changes in comparison to most recent ECG;
- •Recent (within 3 months) cardiac arrest, unstable angina, cerebro-vascular accident (CVA), CABG or PCI
- •Any pacemaker or defibrillator implanted within the last three months;
- •Inability to remain in camera for approximately 60 minutes
- •Bronchospasm
- •Serum creatinine > 2 mg/dL;
- •Cancer patients who have received chemotherapy or radiation therapy within the past 60 days.
- •Any exposure to any investigational drug(s) or medical device(s) within four (4) weeks prior to imaging study;
- •Any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination.
- •NYHA Class III or IV Congestive heart failure;
- •Subject has symptomatic hypotension
- •Allergic or intolerant to aminophylline, nitroglycerin or metoprolol
- •Allergic or intolerant to regadenoson or any of its excipients
- •Prior participants in the study.
- •Female subjects only: Positive serum and/or urine pregnancy test or is lactating or the possibility of pregnancy cannot be ruled out prior to dosing.
- •Females not of child-bearing potential require confirmatory documentation in their medical records or must have a negative pregnancy test within 4 hours prior to receiving the test drug and agree to use an acceptable form of birth control for at least 30 days following BFPET administration.
排除标准
- 未提供
研究组 & 干预措施
BFPET
Experimental
BFPET will be administered as a single intravenous injection of up to 2 mCi (74 MBq) at rest and a single intravenous injection of up to 8mCi (296 MBq) following a stress protocol. Total amount not to exceed 10mCi (370 MBq).
干预措施: BFPET (Drug)
结局指标
主要结局
Sensitivity and specificity of BFPET
时间窗: Up to 30 days
To evaluate the diagnostic performance of BFPET as a PET agent assessment of myocardial perfusion in known or suspected CAD subjects.
次要结局
- Primary safety endpoints - ECG, physical examinations, vital signs, laboratory and adverse event assessments(Up to 10 days)
研究者
研究点 (1)
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