Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature
This study is being done to improve understanding of the cardiovascular effects of ICI therapy.
Inclusion Criteria
- AIM 1: * Treated for cancer at UPHS with immune checkpoint inhibitor therapy * At least 18 years of age at cancer diagnosis AIM 2: * ≥ 18 years of age * Diagnosis of melanoma and planned to undergo adjuvant therapy with immune checkpoint inhibitors * Able to provide written informed consent
Exclusion Criteria
- AIM 1: * Patient treated with novel investigational agent(s) may be excluded on an agent by agent basis to limit heterogeneity and confounding AIM 2: * Pregnant or breast-feeding: Due to risks and potential harm to the unborn fetus, a negative pregnancy test within 10 days prior to the baseline visit is required in women with child-bearing potential. Due to potential nursing infant harm, women who are currently breast-feeding are not eligible for this study. Women are considered postmenopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea or have had a surgical bilateral oophorectomy or tubal ligation * Prior treatment with ICI therapy * Vulnerable patients, including pregnant women and prisoners * Absolute contraindication to rest/vasodilator stress PET/CT, including: ** Known Mobitz type II AV block, third degree AV block, or sick sinus syndrome, without a pacemaker ** Systolic blood pressure < 90mmHg (average over the month prior to enrollment) ** Known hypersensitivity to regadenson and adenosine (hypersensitivity to one of the two agents is not necessarily exclusionary, but will be reviewed with nuclear cardiology locally or at the core lab) ** Profound sinus bradycardia (heart rate < 40bpm) (average over the month prior to enrollment)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06332131.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
PRIMARY OBJECTIVES:
I. To determine the incidence of cardiovascular risk factors and diseases (including new acute coronary syndrome/MI, coronary revascularization, new heart failure/cardiomyopathy, new stroke, new myocarditis, new/worsened hypertension, new/worsened arrhythmia) following ICI therapy. (Aim 1)
II. To determine the incidence of abnormal myocardial blood flow reserve (MBFR) measured by PET stress test. (Aim 2)
OUTLINE: This is an observational study. Patients are assigned to 1 of 2 aims.
AIM 1: Patients have their medical records reviewed on study.
AIM 2: Patients undergo PET scans, CT scans, echocardiography and blood sample collections, complete surveys, and have their medical records reviewed throughout the study.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorMarielle Scherrer-Crosbie
- Primary IDUPCC 07623
- Secondary IDsNCI-2024-09044
- ClinicalTrials.gov IDNCT06332131