[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636936":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":10,"responsibleParty":25,"collaborators":10,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":10,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":10,"enrollmentInfo":36,"targetDuration":10,"studyType":39,"phases":10,"briefSummary":40,"conditions":41,"keywords":43,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":10},{"fullName":5,"class":6},"Lumicell, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Post-market safety population injected with LUMISIGHT",null,"The analysis population consists of the post-market safety population who are injected with LUMISIGHT. The post-market safety population is defined by the indication for use and contraindications as described in the Prescribing Information for LUMISIGHT under NDA 214511.",[13],{"name":14,"affiliation":5,"role":15},"Jorge Ferrer, PhD","PRINCIPAL_INVESTIGATOR",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"VP, Clinical Affairs and Pharmacovigilance","CONTACT","6174041033","kate@lumicell.com",{"name":23,"role":19,"phone":10,"phoneExt":10,"email":24},"Senior Clinical Trial Manager","ppalacios@lumicell.com",{"type":26,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100636936","post-market-safety-study-of-lumisight-100636936",false,"NCT07572162","Post-market Safety Study of LUMISIGHT","Post-market Evaluation of Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration","Inclusion Criteria:\n\n* 18 years of age or older\n* Has been diagnosed with primary breast cancer and scheduled to undergo a lumpectomy procedure\n* Indicated to receive LUMISIGHT at a dose of 1 mg\u002Fkg\n* Willing and able to comply with the study procedures\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions to pegulicianine.\n* Inability to comply with the requirements of the protocol.\n* Treating physician does not think it is in the best interest of the patient to participate.","ALL","18 Years",{"count":37,"type":38},1500,"ESTIMATED","OBSERVATIONAL","This study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with breast cancer undergoing lumpectomy surgery. Participants are indicated to receive LUMISIGHT as part of their breast cancer care. There is no investigational drug associated with this study. LUMISIGHT has a risk of serious hypersensitivity reaction, and this study seeks to further evaluate that risk.",[42],"Hypersensitivity Reactions",[44,45,46,47,48,49,50,51,52,53],"Lumicell","LumiSystem","LUMISIGHT","Breast Cancer","Intraoperative margin detection","anaphylaxis","hypersensitivity","drug allergy","post-market safety","fluorescence guided surgery","NOT_YET_RECRUITING","2026-04-30",{"date":57,"type":58},"2026-05-07","ACTUAL",{"date":60,"type":38},"2026-06",{"date":62,"type":38},"2030-12",{"name":5,"class":6}]