ClinicalTrials.gg
Active, not recruitingNCT06332131Updated Oct 5, 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. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Abramson Cancer Center at Penn Medicine · Observational

Updated Oct 5, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

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

Keywords

  • cancer therapy related cardiotoxicity
  • Immune checkpoint inhibitor therapy
03

In context

Cardiotoxicity

262 studies on the registry are indexed under Cardiotoxicity; 75 are open to participants now.

This study's planned enrollment of 25 is below the median of 111 across 124 observational studies indexed under Cardiotoxicity.

Browse Cardiotoxicity studies →

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 460 studies on the registry; 87 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

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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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 treatment that includes pembrolizumab
  • Able to provide written

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breast-feeding:
  • Prior treatment with ICI therapy.
  • Vulnerable patients, including pregnant women and prisoners
  • Absolute to rest/vasodilator stress PET/CT
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

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

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Enrolling by invitation→Active, not recruiting
changed Oct 5, 2026
Primary completion
Jul 2026→Nov 2026
Oct 5, 2026
Study completion
Jul 2026→Nov 2026
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Enrolling by invitation→Active, not recruiting
    Primary completion Jul 2026→Nov 2026
    Study completion Jul 2026→Nov 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT06332131
Responsible party
Sponsor
First posted
Mar 27, 2024
Start date
Jan 15, 2025
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Oct 5, 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 ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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