Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06332131

Enrollment

Registered

2024-03-27

Start date

2025-01-15

Completion date

2026-07-01

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Cardiotoxicity, Coronary Microvascular Dysfunction, Lung Cancer (NSCLC)

Keywords

cancer therapy related cardiotoxicity, Immune checkpoint inhibitor therapy

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of new abnormal myocardial blood flow reserve (MBFR)	3 months	Development of MBFR\<2

Secondary

Measure	Time frame	Description
Coronary calcium score	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.
All cause mortality	3 months	All cause mortality
Cardiovascular specific mortality	3 months	Cardiovascular specific mortality
Incidence of major cardiovascular events	3 months	Composite measure including new/worsened heart failure, MI, stroke, myocarditis

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMarielle Scherrer-Crosbie, MD, PhD

University of Pennsylvania

Outcome results