Serial PET MPI in Patients Undergoing Cancer Treatment

University of California, Los Angeles (UCLA)

Status: Invitation-only

Conditions: Coronary Artery Disease; Coronary Microvascular Disease; Chemotherapeutic Toxicity; Cancer

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05913999

IRBNet 1668650-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

Anthracycline

Description:

Patients undergoing chemotherapy with an anthracycline-containing regimen.

VEGF Inhibitor

Description:

Patients undergoing chemotherapy with a vascular endothelial growth factor (VEGF) inhibitor-containing regimen.

Immune Checkpoint Inhibitor

Description:

Patients undergoing chemotherapy with an immune check point inhibitor-containing regimen.