Enrolling by invitation NCT06332131
Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Microvascular Dysfunction, Cardiotoxicity, Breast Cancer, Lung Cancer (NSCLC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Incidence of new abnormal myocardial blood flow reserve (MBFR) [Time frame: 3 months]
Secondary outcome measures (4)
- Incidence of major cardiovascular events [Time frame: 3 months]
- Coronary calcium score [Time frame: 3 month]
- All cause mortality [Time frame: 3 months]
- Cardiovascular specific mortality [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Abramson Cancer Center at University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT06332131 · UPCC07623