[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620812":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":62,"collaborators":66,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":19,"enrollmentInfo":78,"targetDuration":19,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":96,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"St. Antonius Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ICG-fluorescence imaging with 99mTc control for SLNB","EXPERIMENTAL","This experimental arm involves participants receiving indocyanine green (ICG) fluorescence imaging as the primary method for sentinel lymph node biopsy (SLNB), with 99mTc-nanocolloid serving as the within-patient control. Both methods are applied during the same surgical procedure. This design allows each participant to serve as their own control for comparing the diagnostic perfomance of both techniques directly in indentifying sentinel lymph nodes via mastectomy incision.",[13],"Other: Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy","ICG-fluorescence is used as the primary tracer to identify SLNs during SLNB in breast cancer surgery. The standard 99mTc-nanocolloid method is used as a control to verify the sentinel lymph nodes identified by ICG. Surgeons are blinded to preoperative lymphoscintigraphy results. After general anesthesia, 5 mg (2 mL of 2.5 mg\u002FmL solutio) of ICG is injected sub-\u002Fintracutaneous periareolarly. ICG-fluorescence is detected using near-infrared imaging. SLNB via mastectomy incision is performed. The most fluorescent lymph node is excised first, followed by (maximal 2) additional fluorescent nodes. The excised nodes are tested for 99mTc-activity using a gamma probe. The axilla is then checked with the gamma probe and and palpation for any remaining nodes, which are excised if their radiation count exceeds 10% of the hottest node. All excised lymph nodes are sent for pathological examination to determine the presence of cancer cells. After surgery, the lymphoscintigraphy results are announced.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Isabelle Henskens, MD","CONTACT","+31883202902","i.henskens@antoniusziekenhuis.nl",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Annemiek Doeksen, MD, PhD","+3183202900","a.doeksen@antoniusziekenhuis.nl",[31,50],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Isala","RECRUITING","Zwolle","Overijssel","8025 AB","Netherlands","NL",{"type":40,"coordinates":41},"Point",[42,43],6.09444,52.5125,{"lat":43,"lon":42},[46],{"name":47,"role":23,"phone":48,"phoneExt":19,"email":49},"Maarten Beek, MD, PhD","+3188 624 50 00","m.a.beek@isala.nl",{"facility":51,"status":33,"city":52,"state":52,"zip":53,"country":37,"countryCode":38,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"St. Antonius Ziekenhuis","Utrecht","3543 AZ",{"type":40,"coordinates":55},[56,57],5.12222,52.09083,{"lat":57,"lon":56},[60,61],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Isabelle Henskens","Coordinating investigator",[67],{"name":32,"class":6},"100620812","finding-sentinel-lymph-nodes-during-mastectomy-using-indocyanine-green-inigma-study-100620812",false,"NCT07362485","Finding Sentinel Lymph Nodes During Mastectomy Using Indocyanine Green (INIGMA Study)","Indocyanine Green Guided Identification of Sentinel Lymph Nodes Via Mastectomy Incision in Breast Cancer Patients (INIGMA Study)","INIGMA","Inclusion Criteria:\n\n* Clinically node-negative, DCIS, invasive T1- T3 breast cancer confirmed by biopsy.\n* Preoperative axillary ultrasound to confirm clinical node-negative status.\n* Indication (or preference) for mastectomy and simultaneous SLN procedure.\n* Written informed consent according to ICH\u002FGCP and national regulations.\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years old\n* Breast conserving surgery\n* Direct reconstruction (with autologous tissue or implant)\n* Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc), intravenous contrast or iodine\n* Other concurrent solid tumour\n* Hyperthyroidism or thyroid cancer\n* Pregnancy or breast feeding\n* Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol","FEMALE","18 Years",{"count":79,"type":80},90,"ESTIMATED","INTERVENTIONAL",[83],"NA","This pilot study evaluates the diagnostic value of indocyanine green (ICG) fluorescence for sentinel lymph node biopsy (SLNB) performed through the mastectomy incision in breast cancer patients.\n\nWomen with clinically node-negative, invasive T1-T3 breast cancer undergoing mastectomy with SLNB at St. Antonius or Isala Hospital will be included. All patients receive standard 99mTc injection preoperatively, followed by 5 mg (2mL) ICG injection after anesthesia. The axilla will be explored for fluorescent lymph nodes via the mastectomy incision, avoiding a separate axillary incision.\n\nPrimary outcome: ICG detection rate for SLN identification via the mastectomy incision.\n\nSecondary outcomes: Comparison with 99mTc detection, number of nodes identified, concordance between methods, pathology differences, detection time, and complications.\n\nICG is safe, non-ionizing, and causes no extra discomfort or visits. Risks and burden are minimal.",[86,87,88,89,90,91,92,93,94,95],"Breast Cancer","Sentinel Lymph Node Biopsy (SLNB)","Sentinel Lymph Node Detection","Sentinel Lymph Node","Lymphatic Metastasis","Fluorescence Imaging","Indocyanine Green (ICG)","Radioisotopes","Lymph Node Mapping","Mastectomy",[97,98,99,95,100,101,102,103,104],"Breast cancer","Sentinel lymph node biopsy","Indocyanine green","Fluorescence imaging","Lymph node mapping","Surgical oncology","Techetium nanocolloïd","Radioisotope","2026-01-15",{"date":107,"type":108},"2026-01-23","ACTUAL",{"date":110,"type":108},"2022-08-22",{"date":112,"type":80},"2026-06",{"name":64,"class":6},2]