Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

• Conditions: Coronary Microvascular Dysfunction; Cardiotoxicity; Breast Cancer; Lung Cancer (NSCLC)

• Registration Number: NCT06332131
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-27
• Status Verified: 2025-01
• Study Start: 2025-01-15
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of new abnormal myocardial blood flow reserve (MBFR)	3 months	Development of MBFR\<2

Secondary Outcome Measures

Name	Time	Method
Incidence of major cardiovascular events	3 months	Composite measure including new/worsened heart failure, MI, stroke, myocarditis
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

Trial Locations

Locations (1)

Abramson Cancer Center at University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States