Serial PET MPI in Patients Undergoing Cancer Treatment

June 12, 2023 updated by: Rene R. Sevag Packard, MD, PhD, University of California, Los Angeles

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Anthracycline
Patients undergoing chemotherapy with an anthracycline-containing regimen.
VEGF Inhibitor
Patients undergoing chemotherapy with a vascular endothelial growth factor (VEGF) inhibitor-containing regimen.
Immune Checkpoint Inhibitor
Patients undergoing chemotherapy with an immune check point inhibitor-containing regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transthoracic echocardiography (TTE) global left ventricular systolic function.
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 global systolic dysfunction measured as % left ventricular ejection fraction by TTE.
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.
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 focal systolic dysfunction measured as % left ventricular global longitudinal strain by TTE.
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 atrial systolic function.
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 focal systolic dysfunction measured as % left atrial strain by TTE.
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.
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 any of the following ECG changes:

  • new T-wave inversions
  • new ST-segment deviations >/= 1mm
  • new left bundle branch block
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
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 changes in the values of serological tests indicative of metabolic or cardiac function abnormalities including one or more of the following:

  • high sensitivity troponin (ng/L)
  • cardiac C-reactive protein (mg/L)
  • brain-type natriuretic peptide (pg/mL)
  • fasting lipid panel: total cholesterol (mg/dL), low-density lipoprotein cholesterol (mg/dL), high-density lipoprotein cholesterol (mg/dL), triglycerides (mg/dL)
  • complete metabolic panel: total protein (g/dL), albumin (g/dL), total bilirubin (mg/dL), direct bilirubin (mg/dL), aspartate aminotransferase (IU/L), alanine transaminase (IU/L), alkaline phosphatase (IU/L), sodium (mmol/L), potassium (mmol/L), chloride (mmol/L), bicarbonate (mmol/L), blood urea nitrogen (mg/dL), creatinine (mg/dL), glucose (mg/dL)
  • complete blood count: white blood cell count (k/uL), hemoglobin (g/dL), hematocrit (%), platelet (k/uL)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

VA Greater Los Angeles Healthcare System

Investigators

  • Principal Investigator: Rene Packard, MD, PhD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBNet 1668650-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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