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Enrolling by Invitation

NCT Number: NCT06332131

Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

This is an observational study that includes patients with breast cancer or non-small cell lung cancer who will be treated with immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system.

Enrolling by Invitation

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Key information

Conditions

Coronary Microvascular Dysfunction Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Lung Cancer (NSCLC) Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥18 years of age
  • Either diagnosis of breast cancer with plan for treatment according to the Keynote 522 regimen or non-small-cell lung cancer planned for neoadjuvant treatment that includes pembrolizumab
  • Able to provide written informed consent

Exclusion criteria

  • Pregnant or breast-feeding:
  • Prior treatment with ICI therapy.
  • Vulnerable patients, including pregnant women and prisoners
  • Absolute Contraindication to rest/vasodilator stress PET/CT

Treatment and study plan

Primary outcomes

  1. Incidence of new abnormal myocardial blood flow reserve (MBFR)

    Time frame: 3 months

    Development of MBFR<2

Secondary outcomes

  1. Incidence of major cardiovascular events

    Time frame: 3 months

    Composite measure including new/worsened heart failure, MI, stroke, myocarditis

  2. Coronary calcium score

    Time frame: 3 month

    Change in PET derived Coronary Calcium (CAC) Score from baseline. CAC ranges from 0-400 agatson units; higher CAC indicates larger amounts of calcium are present in the coronary arteries.

  3. All cause mortality

    Time frame: 3 months

    All cause mortality

  4. Cardiovascular specific mortality

    Time frame: 3 months

    Cardiovascular specific mortality

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2024
Registry last updated
Feb 9, 2026

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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