Prospective Evaluation of Chemotherapy-Induced Cardiotoxicity by Serial PET Myocardial Perfusion and Blood Flow Assessment - the PRECISION 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
- PET myocardial blood flow (MBF) measurement.
研究概览
简要总结
This study aims to evaluate the effects of cardiotoxic cancer therapies on myocardial blood flow (MBF) and perfusion in a prospective sample of VA patients.
详细描述
Up to 60 patients who will be newly initiating chemotherapy are going to be prospectively evaluated using PET myocardial perfusion imaging (MPI) for chemotherapy-induced cardiotoxicity by quantifying MBF and perfusion. Patients will be grouped into 3 categories:
- Patients undergoing chemotherapy with anthracycline containing regimen.
- Patients undergoing chemotherapy with VEGF inhibitor containing regimen.
- Patients undergoing chemotherapy with immune check point inhibitor containing regimen.
Patients will undergo PET MPI at 3 different time points:
- Baseline PET MPI within 1 month prior to initiation of the chemotherapy regimen.
- PET MPI at the middle of the chemotherapy regimen.
- PET MPI within 1 month following completion of the chemotherapy regimen.
For PET MPI, the investigators will evaluate for abnormalities such as new perfusion defects, decreases in stress myocardial blood flows and decreases in myocardial flow reserves.
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
- •Veterans Affairs oncology patients who will be initiating chemotherapy
- •Ability to give consent
排除标准
- •Prior chemotherapy
- •Prior coronary revascularization (percutaneous coronary intervention, coronary artery bypass grafting)
- •Anyone with previous invasive or CT (computed tomography) angiogram demonstrating any lesion ≥ 50% stenosis
- •Known cardiomyopathy defined as rest ejection fraction < 50%
- •History of heart and/or another organ transplant
- •Pregnancy or breast-feeding status
结局指标
主要结局
PET myocardial blood flow (MBF) measurement.
时间窗: Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months)
Change from baseline in number of patients with myocardial blood flow abnormalities measured as stress myocardial blood flow (SMBF) values \< 2 mL/min/g of left ventricular myocardium by PET
PET myocardial perfusion imaging (MPI).
时间窗: Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months)
Change from baseline in number of patients with perfusion defects measured as % total perfusion deficit (TPD) of the left ventricular myocardium by PET
次要结局
- Transthoracic echocardiography (TTE) focal left atrial systolic function.(Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months))
- Transthoracic echocardiography (TTE) focal left ventricular systolic function.(Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months))
- Metabolic or cardiac function abnormalities as determined by blood work findings(Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months))
- Transthoracic echocardiography (TTE) global left ventricular systolic function.(Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months))
- Electrocardiogram (ECG) findings.(Baseline (within 1 month prior to the initiation of cancer treatment), during cancer treatment (estimated at 1-6 months), and within 1 month post-cancer treatment completion (approximately 2-9 months))
研究者
Rene R. Sevag Packard, MD, PhD
Assistant Professor-in-Residence
University of California, Los Angeles