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Enrolling by Invitation

NCT Number: NCT05913999

Serial PET MPI in Patients Undergoing Cancer Treatment

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.

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Key information

Conditions

Cancer Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chemotherapeutic Toxicity Coronary Artery Disease Coronary Disease Coronary Microvascular Disease Heart Diseases Microvascular Angina Myocardial Ischemia Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West Los Angeles VA Medical Center

Los Angeles, California, 90073, United States

About this study

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:

  • Patients undergoing chemotherapy with anthracycline containing regimen.
  • Patients undergoing chemotherapy with VEGF inhibitor containing regimen.
  • Patients undergoing chemotherapy with immune check point inhibitor containing regimen.

Patients will undergo PET MPI at 3 different time points:

  • Baseline PET MPI within 1 month prior to initiation of the chemotherapy regimen.
  • PET MPI at the middle of the chemotherapy regimen.
  • 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:

  • Echocardiogram with strain analysis within +/- 1 week of each PET MPI
  • 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.
  • 12-lead ECG with each PET MPI study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • VA Greater Los Angeles Healthcare System

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2023
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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