CClinicalTrials.gg
Enrolling by invitationNCT06332131Updated Feb 9, 2026

Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature

An observational study in Coronary Microvascular Dysfunction, Cardiotoxicity and Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Abramson Cancer Center at Penn Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • cancer therapy related cardiotoxicity
  • Immune checkpoint inhibitor therapy
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
05

What researchers measure

Primary outcomes

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

    Development of MBFR\<2

    Time frame: 3 months

Secondary outcomes

  1. Incidence of major cardiovascular events

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

    Time frame: 3 months

  2. 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

  3. All cause mortality

    All cause mortality

    Time frame: 3 months

  4. Cardiovascular specific mortality

    Cardiovascular specific mortality

    Time frame: 3 months

06

Study locations

1 site
  • Abramson Cancer Center at University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT06332131
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Sponsor
First posted
Mar 27, 2024
Start date
Jan 15, 2025
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Feb 9, 2026

Study contacts

Marielle Scherrer-Crosbie, MD, PhD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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