[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06332131":3,"trial-entities:NCT06332131":82,"trial-summary:NCT06332131":87},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":25,"primary_purpose":16,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":31,"secondary_outcomes":36,"sex":48,"minimum_age":49,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":50,"std_ages":61,"locations":64,"central_contacts":74,"overall_officials":75,"references":80,"see_also_links":81},"NCT06332131","UPCC07623","Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature","ENROLLING_BY_INVITATION","2026-07","2026-02","2026-02-09","2025-01-15","Abramson Cancer Center at Penn Medicine","OTHER",false,"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.",null,[18,19,20,21],"Coronary Microvascular Dysfunction","Cardiotoxicity","Breast Cancer","Lung Cancer (NSCLC)",[23,24],"cancer therapy related cardiotoxicity","Immune checkpoint inhibitor therapy","OBSERVATIONAL",[],{"count":28,"type":29},25,"ESTIMATED",[],[32],{"measure":33,"description":34,"timeFrame":35},"Incidence of new abnormal myocardial blood flow reserve (MBFR)","Development of MBFR\\\u003C2","3 months",[37,40,44,46],{"measure":38,"description":39,"timeFrame":35},"Incidence of major cardiovascular events","Composite measure including new\u002Fworsened heart failure, MI, stroke, myocarditis",{"measure":41,"description":42,"timeFrame":43},"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.","3 month",{"measure":45,"description":45,"timeFrame":35},"All cause mortality",{"measure":47,"description":47,"timeFrame":35},"Cardiovascular specific mortality","ALL","18 Years",{"inclusion":51,"exclusion":55,"raw_text":60},[52,53,54],"≥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",[56,57,58,59],"Pregnant or breast-feeding:","Prior treatment with ICI therapy.","Vulnerable patients, including pregnant women and prisoners","Absolute Contraindication to rest\u002Fvasodilator stress PET\u002FCT","Inclusion Criteria:\n\n* ≥18 years of age\n* 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\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding:\n* Prior treatment with ICI therapy.\n* Vulnerable patients, including pregnant women and prisoners\n* Absolute Contraindication to rest\u002Fvasodilator stress PET\u002FCT",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":66,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"Abramson Cancer Center at University of Pennsylvania","Philadelphia","Pennsylvania","19104","United States",{"lat":72,"lon":73},39.95238,-75.16362,[],[76],{"name":77,"affiliation":78,"role":79},"Marielle Scherrer-Crosbie, MD, PhD","University of Pennsylvania","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":83,"biomarkers":86},[84,85],"Breast Carcinoma","Lung Non-Small Cell Carcinoma",[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]