Prospective Evaluation of Chemotherapy-Induced Cardiotoxicity by Serial PET Myocardial Perfusion and Blood Flow Assessment - the PRECISION Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of California, Los Angeles
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- PET myocardial blood flow (MBF) measurement.
- Status
- Enrolling By Invitation
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Detailed Description
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: 1. Patients undergoing chemotherapy with anthracycline containing regimen. 2. Patients undergoing chemotherapy with VEGF inhibitor containing regimen. 3. Patients undergoing chemotherapy with immune check point inhibitor containing regimen. Patients will undergo PET MPI at 3 different time points: 1. Baseline PET MPI within 1 month prior to initiation of the chemotherapy regimen. 2. PET MPI at the middle of the chemotherapy regimen. 3. 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. All study patients will also be analyzed using the following tests: 1. Echocardiogram with strain analysis within +/- 1 week of each PET MPI 2. Serology - high sensitivity troponin, cardiac C-reactive protein (CRP), brain-type natriuretic peptide (BNP), fasting lipid panel, complete metabolic panel, and complete blood count within +/- 1 week of each PET MPI study. 3. 12-lead ECG with each PET MPI study.
Investigators
Rene R. Sevag Packard, MD, PhD
Assistant Professor-in-Residence
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- •Veterans Affairs oncology patients who will be initiating chemotherapy
- •Ability to give consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
PET myocardial blood flow (MBF) measurement.
Time Frame: 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).
Time Frame: 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
Secondary Outcomes
- 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))