[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586142":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":46,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":72,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intraoperative Assessment","EXPERIMENTAL","After screening and enrollment, the EndoScell Scaner (ES) novel intraoperative cellular probing technology will be used for intraoperative evaluation of the sentinel lymph node. Concurrently, imprint cytology will be performed for evaluation. During the study period, intraoperative decisions will primarily reference the results of the imprint cytology technique.",[13],"Procedure: EndoScell Scaner (ES) novel intraoperative cellular probing technology",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","EndoScell Scaner (ES) novel intraoperative cellular probing technology","In this project, we utilize the miniature wide-angle focusing microscope for intraoperative cell-level observation and detection, a technology in which our hospital has conducted extensive research and accumulated rich experience.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Jiajian Chen, Doctor","CONTACT","+8618017317219","elwin1020@163.com",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":37,"coordinates":38},"Point",[39,40],121.45806,31.22222,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":45,"phoneExt":20,"email":26},"Jiajian Chen","+86 21 64175590",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Jiong Wu","Professor","100586142","application-of-endoscell-intraoperative-cellular-probing-technology-for-early-stage-breast-cancer-100586142",false,"NCT06911528","Application of EndoScell Intraoperative Cellular Probing Technology for Early-Stage Breast Cancer","A Prospective Study to Evaluate the Application of EndoScell Intraoperative Cellular Probing Technology in Breast Conserving Therapy and Sentinel Lymph Node Biopsy for Early-Stage Breast Cancer","EDGE","Inclusion Criteria:\n\n* Age 18 years and older (inclusive)\n* Female\n* Preoperative pathology confirmed invasive breast carcinoma or ductal carcinoma in situ\n* Scheduled for sentinel lymph node biopsy\n* Capable of and willing to provide informed consent\n\nExclusion Criteria:\n\n* Patients with a confirmed allergy to methylene blue or sodium citrate tracers\n* Pregnant or lactating women\n* Patients unwilling to participate in the clinical study","FEMALE","18 Years",{"count":61,"type":62},709,"ESTIMATED","INTERVENTIONAL",[65],"NA","Sentinel Lymph Node Biopsy (SLNB) is a common surgical treatment for breast cancer and a primary method for assessing the pathological status of axillary lymph nodes. Precise intraoperative detection of sentinel lymph nodes during surgery assists in timely evaluation of axillary lymph node pathology and helps in formulating further treatment strategies.\n\nTouch imprint cytology (TIC) is one of the most commonly used intraoperative detection techniques. The new intraoperative cellular detection technology, EndoScell Scanner (ES), uses an improved real-time miniaturized fluorescence microscopy system for image acquisition. The ultra-high-resolution images obtained can reach the cellular level. In previous studies, the accuracy and sensitivity of this technology for intraoperative detection of sentinel lymph nodes were comparable to imprint cytology, but it is much more rapid. The detection technology uses fluorescein sodium and methylene blue as fluorescent dyes, which is non-invasive and also non-consumptive of tissue samples.\n\nThis study involves patients scheduled for sentinel lymph node biopsy and aims to evaluate the clinical application value of the EndoScell Scanner (ES) for intraoperative assessment of the pathological status of sentinel lymph nodes through a prospective self-controlled study. To avoid the potential impact of methylene blue on the ES detection technology, we will use mitoxantrone as a new dye for sentinel lymph node tracing in this study.\n\nThe primary study objective is to compare the accuracy of the ES detection technology in assessing sentinel lymph node status, using paraffin pathology examination as the gold standard. The primary endpoint is the accuracy of the ES technology. Secondary endpoints include the image quality score of the ES detection, the learning curve of the surgeons, and the time required for detection.",[68,69,70,71],"Breast Cancer","Sentinel Lymph Node","Frozen Section","Cytology",[73,74,75,76,77],"Breast carcinoma","sentinel lymph node","tracer","touch imprint cytology","epifluorescence widefield microscope system","2025-03-28",{"date":80,"type":81},"2025-04-04","ACTUAL",{"date":83,"type":81},"2024-01-30",{"date":85,"type":62},"2025-12-31",{"name":5,"class":6},1]