Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Rene Packard, MD, PhD
Headshot of Rene Packard
Rene Packard

Description

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.

Official Title

Prospective Evaluation of Chemotherapy-Induced Cardiotoxicity by Serial PET Myocardial Perfusion and Blood Flow Assessment - the PRECISION Trial

Details

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.

Keywords

Cancer, Chemotherapeutic Toxicity, Coronary Artery Disease, Coronary Microvascular Disease, Microvascular Angina, Anthracycline, VEGF Inhibitor, Immune Checkpoint Inhibitor

Eligibility

You can join if…

Open to people ages 18 years and up

  • Veterans Affairs oncology patients who will be initiating chemotherapy
  • Ability to give consent

You CAN'T join if...

  • 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

Location

  • West Los Angeles VA Medical Center
    Los Angeles California 90073 United States

Lead Scientist at UCLA

  • Rene Packard, MD, PhD
    Associate Professor-in-residence, Medicine. Authored (or co-authored) 53 research publications

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05913999
Study Type
Observational
Participants
Expecting 60 study participants
Last Updated