Clinical trial NCT05913999: Serial PET MPI in Patients Undergoing Cancer Treatment
Official title: Prospective Evaluation of Chemotherapy-Induced Cardiotoxicity by Serial PET Myocardial Perfusion and Blood Flow Assessment - the PRECISION Trial
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cancer
Chemotherapeutic Toxicity
Coronary Artery Disease
Coronary Microvascular Disease
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: VA Greater Los Angeles Healthcare System
First posted: 2023-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with cancer receiving medical care at the West Los Angeles Veterans Affairs Medical Center / Greater Los Angeles Veterans Affairs Healthcare System.

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.

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

Primary outcomes:
measure: PET myocardial perfusion imaging (MPI).
timeFrame: 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)
measure: PET myocardial blood flow (MBF) measurement.
timeFrame: 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)
Secondary outcomes:
measure: Transthoracic echocardiography (TTE) global left ventricular systolic function.
timeFrame: 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)
measure: Transthoracic echocardiography (TTE) focal left ventricular systolic function.
timeFrame: 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)
measure: Transthoracic echocardiography (TTE) focal left atrial systolic function.
timeFrame: 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)
measure: Electrocardiogram (ECG) findings.
timeFrame: 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)
measure: Metabolic or cardiac function abnormalities as determined by blood work findings
timeFrame: 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)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: West Los Angeles VA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Rene Packard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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