Clinical trial · Observational
Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature
NCT06332131CI-TRIAL-00102803enrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiotoxicity | — | UNRESOLVED | — |
| Coronary Microvascular Dysfunction | — | UNRESOLVED | — |
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of new abnormal myocardial blood flow reserve (MBFR)
- timeFrame
- 3 months
- description
- Development of MBFR\<2
Secondary outcomes (4)
- measure
- Incidence of major cardiovascular events
- timeFrame
- 3 months
- description
- Composite measure including new/worsened heart failure, MI, stroke, myocarditis
- measure
- Coronary calcium score
- timeFrame
- 3 month
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.