[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"invasive-lobular-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:invasive-lobular-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":5},"100633498","hismar-intraoperative-margin-assessment-using-the-histolog-scanner-to-reduce-reoperation-in-breast-conserving-surgery-100633498",false,"NCT07527468","HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving Surgery","HISMAR: A Prospective Post-Market Performance Follow-up Study of the Histolog Scanner for Intraoperative Margin Assessment in Breast-Conserving Surgery for High-Risk Histological Subtypes (ILC, DCIS, NST+DCIS)","HISMAR","1. Female patient, aged 18 years or older at time of surgery.\n2. Pre-operative core needle biopsy (CNB) or vacuum-assisted biopsy (VAB) with histological diagnosis of one of the following:\n\n   1. invasive lobular carcinoma (ILC\u002FCLI),\n   2. pure ductal carcinoma in situ (DCIS), or\n   3. invasive carcinoma of non-special type (NST) with an associated DCIS component.\n3. Planned breast-conserving surgery (BCS \u002F lumpectomy) at CHVR.\n4. Signed electronic informed consent (eIC) obtained prior to any study procedure.\n\nExclusion Criteria:\n\n1. Pregnancy (confirmed or suspected) at time of surgery.\n2. Prior neo-adjuvant treatment (hormonal therapy or chemotherapy) for the current breast cancer diagnosis.\n3. Surgical indication for mastectomy rather than BCS.\n4. Known hypersensitivity or allergy to acriflavine (fluorescent staining agent used with the Histolog Scanner).\n5. Incapacity to provide informed consent.\n6. Previous enrolment in this study.","FEMALE","18 Years",{"count":20,"type":21},228,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study evaluates whether systematic intraoperative margin assessment using the Histolog® Scanner - a confocal fluorescence microscopy device - reduces the need for reoperation after breast-conserving surgery (lumpectomy) in women with lobular carcinoma (ILC), ductal carcinoma in situ (DCIS), or invasive carcinoma with a DCIS component (NST+DCIS).\n\nAfter lumpectomy, the fresh specimen is imaged in real time by the surgeon using the Histolog® Scanner, which produces histological-quality images of the specimen surface without any tissue processing. This allows immediate assessment of surgical margins in the operating room, enabling the surgeon to perform additional tissue removal if needed before closing.\n\nBased on institutional data from 266 cases at CHVR (2021-2024), the current reoperation rate in this population is 11.3%. The study tests whether systematic use of the Histolog® Scanner in addition to standard care reduces this rate by 50% or more (to ≤5.6%). A total of 228 patients will be enrolled prospectively at the Centre Hospitalier du Valais Romand (CHVR), Sion, Switzerland. The reoperation decision is made by the multidisciplinary tumour board based on final histopathology results, independently of the intraoperative findings.",[27,28,29,30],"Breast Cancer","Ductal Carcinoma In Situ","Invasive Lobular Carcinoma","Breast Neoplasm Female",[32,33,34,35,36,37,38,39,40,41,42,43],"breast-conserving surgery","lumpectomy","surgical margins","intraoperative imaging","confocal microscopy","reoperation","re-excision","histological scanning","DCIS","ILC","post-market performance follow-up","PMPF","NOT_YET_RECRUITING","2026-04-07",{"date":47,"type":48},"2026-04-14","ACTUAL",{"date":50,"type":21},"2026-09-01",{"date":52,"type":21},"2030-06-01",{"name":54,"class":55},"Hôpital du Valais","OTHER"]