[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lumicell, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100639298","post-market-evaluation-of-lumisystem-intraoperative-margin-performance-and-clinical-utility-impact-registry-100639298",false,"NCT07616856","Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry","Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility","IMPACT","Inclusion Criteria:\n\n* Participant must be consistent with FDA approved indication\n\nExclusion Criteria:\n\n* Participant is enrolled in a clinical trial using an investigational product directing tissue removal during the lumpectomy procedure","ALL","18 Years",{"count":20,"type":21},1500,"ESTIMATED","9 Months","OBSERVATIONAL","This is a minimal risk post-market registry study conducted at participating clinical institutions that are utilizing LumiSystem consistent with the U.S. Food and Drug Administration (FDA) approved indication for use to collect data on the use of LumiSystem in a real-world setting to support the evaluation of safety, effectiveness, clinical utility (including impact to healthcare utilization and surgical management), and product and quality improvements.",[26],"Breast Cancer",[26,28,29,30,31,32,33],"Fluorescence guided surgery","intraoperative margin detection","LumiSystem","Lumicell","Lumisight","pegulicianine","NOT_YET_RECRUITING","2026-05-27",{"date":37,"type":38},"2026-06-01","ACTUAL",{"date":40,"type":21},"2026-07",{"date":42,"type":21},"2030-12",{"name":44,"class":45},"Lumicell, Inc.","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":71,"locationsCount":4},"100636936","post-market-safety-study-of-lumisight-100636936","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.",{"count":20,"type":21},"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.",[56],"Hypersensitivity Reactions",[31,30,58,26,59,60,61,62,63,64],"LUMISIGHT","Intraoperative margin detection","anaphylaxis","hypersensitivity","drug allergy","post-market safety","fluorescence guided surgery","2026-04-30",{"date":67,"type":38},"2026-05-07",{"date":69,"type":21},"2026-06",{"date":42,"type":21},{"name":44,"class":45},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":81,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100253922","phase-1-feasibility-of-the-lum-imaging-system-for-detection-of-gastrointestinal-cancers-100253922","NCT02584244","Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers","Inclusion Criteria:\n\n1. Subjects must have histologically or cytologically confirmed esophageal, colorectal or pancreatic adenocarcinoma (inclusive of high grade dysplasia and cystic neoplasms) on a biopsy prior to surgery and must be scheduled for surgical resection, inclusive of endoscopic mucosal resection, of the primary tumor. Subjects at any cancer stage will be enrolled.\n2. Subjects may have previously received pre-operative radiation therapy and neoadjuvant chemotherapy.\n3. Age of 18 years or older.\n4. Subjects must be able and willing to follow study procedures and instructions.\n5. Subjects must have received and signed an informed consent form.\n6. Subjects must be sufficiently healthy to undergo surgery or an endoscopic procedure.\n7. Subjects must have normal organ and marrow function as defined below:\n\n   * Leukocytes \\>\u002F= 3,000\u002FmcL\n   * Absolute neutrophil count \\>\u002F= 1,500\u002FmcL\n   * Platelets \\>\u002F= 100,000\u002FmcL\n   * total bilirubin within normal institutional limits (except in cases of malignant biliary obstruction)\n   * AST (SGOT)\u002FALT (SGPT) \\\u003C\u002F= 2.5 X institutional upper limit of normal (\\\u003C\u002F= 5 x ULN in cases of malignant biliary obstruction)\n   * Creatinine within normal institutional limits or creatinine clearance \\>\u002F= 60 mL\u002Fmin\u002F1.73 m2 for subjects with creatinine levels above institutional normal.\n8. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) starting the day entering the study, and for 60 days after injection of the imaging agent. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n9. Subjects with ECOG performance status of 0 or 1.\n\nExclusion Criteria:\n\n1. Subjects who have taken an investigational drug within 30 days of enrollment.\n2. Subjects with QTc interval \\> 480ms.\n3. Subjects who have not recovered from adverse events due to pharmaceutical or diagnostic agents administered more than 4 weeks earlier.\n4. Subjects with uncontrolled hypertension defined as persistent systolic blood pressure \\> 180 mm Hg, or diastolic blood pressure \\> 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy\n5. History of allergic reaction attributed to drugs containing polyethylene glycol (PEG)\n6. History of allergic reaction to oral or intravenous contrast agents.\n7. Pregnant women or lactating women\n8. Subjects who are sexually active and not willing\u002Fable to use medically acceptable forms of contraception upon entering the study.\n9. HIV-positive individuals on combination antiretroviral therapy.\n10. Any subject for whom the investigator feels participation is not in the best interest of the subject.",{"count":79,"type":21},66,"INTERVENTIONAL",[82,83],"PHASE1","PHASE2","The overall goal of this feasibility study is to assess the initial safety and efficacy of LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM Imaging System.",[86,87,88,89],"Colorectal Cancer","Pancreatic Cancer","Esophageal Cancer","Gastric Cancer","RECRUITING","2026-01-15",{"date":93,"type":38},"2026-01-16",{"date":95,"type":38},"2016-08-04",{"date":97,"type":21},"2027-04",{"name":44,"class":45},1,""]