Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

NCT06332131 | Enrolling By Invitation

• 1 other identifier: UPCC07623
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cancer therapy related cardiotoxicity; Immune checkpoint inhibitor therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of new abnormal myocardial blood flow reserve (MBFR)

  Development of MBFR\<2

  3 months

Secondary Outcomes (4)

• Incidence of major cardiovascular events

  3 months

• Coronary calcium score

  3 month

• All cause mortality

  3 months

• Cardiovascular specific mortality

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast or lung cancer planned for treatment that includes pembrolizumab.

You may qualify if:

• ≥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

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples will be collected and banked

MeSH Terms

Conditions

Cardiotoxicity; Breast Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Marielle Scherrer-Crosbie, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)