Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

N/AEnrolling By InvitationNCT06332131

Abramson Cancer Center at Penn Medicine25 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Microvascular Dysfunction Cardiotoxicity Breast Cancer Lung Cancer (NSCLC)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Incidence of new abnormal myocardial blood flow reserve (MBFR)

Development of MBFR\<2

Time frame: 3 months

Secondary Outcomes

Incidence of major cardiovascular events

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

Time frame: 3 months

Coronary calcium score

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.

Time frame: 3 month

All cause mortality

Time frame: 3 months

Cardiovascular specific mortality

Time frame: 3 months

Data from ClinicalTrials.gov

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