[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radioisotopes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radioisotopes":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,60],{"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":36,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100604190","implementation-of-indocyanine-green-to-identify-sentinel-lymph-nodes-during-surgery-for-breast-cancer-100604190",false,"NCT07146295","Implementation of Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer","Implementation of Fluorescence Imaging Using Indocyanine Green to Identify Sentinel Lymph Nodes During Surgery for Breast Cancer","INFINITE","Inclusion Criteria:\n\n* Patients ≥ 18 years old.\n* DCIS or invasive breast cancer, confirmed by biopsy\n* Clinically node-negative, confirmed by preoperative axillary ultrasound\n* Indication for breast cancer surgery with SLN procedure via axillar incision\n\nExclusion Criteria:\n\n* Combined MARI procedure\n* Known allergy for Indocyanine Green (ICG), intravenous contrast or iodine\n* History of axillary lymph node dissection\n* Hyperthyroidism or thyroid cancer\n* Pregnancy or breast-feeding\n* No written informed consent according to ICH\u002FGCP and national regulations.","ALL","18 Years",{"count":20,"type":21},1760,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn how to successfully introduce a new method for finding the sentinel lymph node during breast cancer surgery into routine hospital care. The method uses a dye called indocyanine green (ICG) and a special camera to see the lymph node. The sentinel lymph node is the first lymph node that cancer is likely to spread to.\n\nIn the Netherlands, about 1 in 7 women develops breast cancer. Finding out whether cancer has spread to the lymph nodes is important for planning treatment and predicting outcomes. The current standard method for sentinel lymph node biopsy (SLNB) uses a radioactive tracer called radioisotope technetium-labeled (99mTc)-nanocolloid. While accurate, this method has several drawbacks: it exposes patients to radioactivity, requires an extra hospital visit or travel to another hospital due to limited nuclear medicine facilities, and is not sustainable. Surgeries using 99mTc can only take place on certain days due to logistical issues, and the signal from 99mTc can be disturbed by the tumor marker placed in the breast.\n\nICG works as well as 99mTc for SLNB and offers several advantages: it is given during surgery (no extra visit needed), produces no radiation, and reduces costs. However, it is still not widely used in the Netherlands because hospitals may not be familiar with it or unsure how to make the switch.\n\nThis study will introduce ICG step-by-step in several Dutch hospitals and evaluate how to make the change as smooth and effective as possible. It will take place in three stages: I) SLNB with 99mTc only (current practice); II) SLNB with both 99mTc and ICG (transition phase); III) SLNB with ICG only (full implementation).\n\nAll study procedures take place during planned surgery, with no extra hospital visits. After surgery, participants will receive a short questionnaire (10-15 minutes) to share their experiences with the procedure. Their feedback, combined with input from healthcare providers, will help researchers develop a uniform medical protocol, an implementation guide, and educational materials for surgeons and surgical trainees.\n\nThe aim is to make ICG widely available across the Netherlands, ensuring that care is less burdensome, more sustainable, and more cost-effective, while keeping treatment accessible in local hospitals.",[27,28,29,30,31,32,33,34,35],"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",[37,38,39,40,41,42,43,44,45,46],"Breast cancer","Sentinel lymph node biopsy","Lymphatic metastasis","Indocyanine green","Techetium nanocolloïd","Fluorescence imaging","Surgical oncology","Lymph node mapping","Implementation","Radioisotope","RECRUITING","2026-06-22",{"date":50,"type":51},"2026-06-25","ACTUAL",{"date":53,"type":51},"2025-04-18",{"date":55,"type":21},"2026-08",{"name":57,"class":58},"Isabelle Henskens","OTHER",7,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":68,"minAge":18,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":5},"100620812","finding-sentinel-lymph-nodes-during-mastectomy-using-indocyanine-green-inigma-study-100620812","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",{"count":70,"type":21},90,[24],"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.",[27,28,29,30,31,32,33,34,35,74],"Mastectomy",[37,38,40,74,42,44,43,41,46],"2026-01-15",{"date":78,"type":51},"2026-01-23",{"date":80,"type":51},"2022-08-22",{"date":82,"type":21},"2026-06",{"name":57,"class":58}]