Comparative Evaluation of 18F-Flurpiridaz and 82Rb-Chloride PET Myocardial Perfusion Imaging: The FLARE (Flurpiridaz vs. Rubidium Evaluation) Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 18F-Flurpiridaz Diagnostic Performance
研究概览
简要总结
This study seeks to evaluate if the diagnostic performance of 18F-flurpiridaz positron emission tomography (PET) myocardial perfusion imaging (MPI), given the radiotracer's properties, is non-inferior to the currently most widely utilized PET MPI radiopharmaceutical, 82Rb-chloride.
详细描述
- Patients will undergo a clinically indicated rest/stress 82Rb-chloride positron emission tomography (PET) myocardial perfusion imaging (MPI) and will return to the nuclear cardiology laboratory within 1-30 days to undergo a 18F-flurpiridaz PET MPI and coronary CT angiogram. A rest 18F-flurpiridaz PET MPI will be acquired first, followed by a stress 18F-flurpiridaz PET MPI. The waiting period between the rest and stress 18F-flurpiridaz PET acquisitions will be ≥ 30 minutes. The rest dose will be 2.5-3.0 mCi, and the pharmacological stress dose will be 6.0-6.5 mCi. All PET MPI studies will be conducted using regadenoson as the pharmacologic stress agent.
- 18F-flurpiridaz and 82Rb-chloride PET MPI scans will be interpreted by three expert visual readers in a blinded manner. Both Image quality and diagnostic certainty will be classified using a five-point scale. If the study is abnormal, the perfusion defect will further be categorized as reversible or fixed. Relative perfusion and myocardial blood flow quantification will be obtained using validated software methods.
- Coronary CT angiograms will similarly be analyzed in a blinded manner by a core lab. Coronary segments with a diameter ≥1.5 mm will be included in the analysis. Each segment will be evaluated for the presence or absence of coronary atherosclerosis, defined as any tissue structure >1 mm^2 within the coronary artery wall differentiated from the surrounding epicardial tissue, epicardial fat, or the vessel lumen itself. Maximal stenosis ratios as well as atherosclerotic plaque characteristics and CT-derived fractional flow reserve (FFR) will be obtained in each coronary territory.
- The paired difference between 18F-flurpiridaz and 82Rb-chloride PET MPI will be evaluating by calculating the receiver operating characteristic area under the curve (ROC AUC) for the sensitivity and specificity of blinded visual reads, automated relative perfusion quantitation, and myocardial blood flow quantification, as well as for image quality and diagnostic certainty assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient scheduled for a clinically indicated 82Rb-chloride PET MPI
- •Age ≥ 18 years
- •Ability to provide consent
排除标准
- •Previous participation in a 18F-flurpiridaz clinical trial
- •Prior myocardial infarction
- •Prior coronary revascularization (percutaneous coronary intervention and/or coronary artery bypass grafting)
- •History of orthotopic heart transplantation
- •Inability to control heart rate < 65 bpm
- •Frequent ventricular or atrial ectopy leading to irregular cardiac rhythm
- •Creatinine ≥ 1.4 mg/dL
- •Pregnant or breast-feeding status
研究组 & 干预措施
Patients Undergoing Myocardial Perfusion Imaging
Patients scheduled for a clinically indicated myocardial perfusion imaging study with 82Rb-chloride who subsequently undergo MPI with 18F-flurpiridaz as well as a CT coronary angiogram.
结局指标
主要结局
18F-Flurpiridaz Diagnostic Performance
时间窗: From enrollment to completion of CT coronary angiography, an average of 10 days
The diagnostic performance of 18F-flurpiridaz compared to 82Rb-chloride PET myocardial perfusion imaging by expert readers using coronary CT angiography as the reference standard * Diagnostic performances will be analyzed on a per-vessel and a per-patient basis using coronary artery disease (CAD) ≥50% and ≥70% stenoses as significance cutoffs and CT-based fractional flow-reserve (FFR) ≤0.80 at the lesion level and at the distal vessel level
次要结局
- Relative Perfusion Analysis(From enrollment to completion of 18F-flurpiridaz PET MPI, an average of 10 days)
- Myocardial Blood Flow Quantification(From enrollment to completion of 18F-flurpiridaz PET MPI, an average of 10 days)
研究者
Rene R. Sevag Packard, MD, PhD
Associate Professor-in-Residence, Departments of Medicine (Cardiology) and Physiology
University of California, Los Angeles