[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sentinel-lymph-node\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sentinel-lymph-node":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,61,87,123,153,177,201,227,266,293,315,337,373,399,425,455,478,507,531,550,570,594,613,635,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":37,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"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":21,"type":22},1760,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31,32,33,34,35,36],"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",[38,39,40,41,42,43,44,45,46,47],"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":51,"type":52},"2026-06-25","ACTUAL",{"date":54,"type":52},"2025-04-18",{"date":56,"type":22},"2026-08",{"name":58,"class":59},"Isabelle Henskens","OTHER",7,{"id":62,"slug":63,"hasResults":12,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":23,"phases":71,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100430810","alnd-vs-art-in-positive-sentinel-node-after-neoadjuvant-therapy-in-breast-cancer-100430810","NCT04889924","ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer","Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study","ADARNAT","Inclusion Criteria:\n\n* T1-T4 N0\u002F T0-T4 N1 at diagnosis and subsidiary of neoadjuvant treatment\n* Post-CT SLN with ≤2 macrometastasis\u002Fmicrometastasis or ITCs\n* Post-CT axillary response by ultrasound or MRI\n* Complete at least 70% of neoadjuvant chemotherapy and 6 months of endocrine treatment.\n\nExclusion Criteria:\n\n* cN2\n* ypN0\n* History of breast surgery for ipsilateral cancer in the last 10 years\n* History of other cancer in the last 5 years, except squamous carcinoma of the skin.",{"count":70,"type":22},820,[25],"In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy.\n\nThe primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.",[28,74,31,75,76],"Chemotherapy","Axillary Lymph Nodes Dissection","Radiotherapy Side Effect","2026-05-18",{"date":79,"type":52},"2026-05-19",{"date":81,"type":52},"2021-06-11",{"date":83,"type":22},"2028-12-31",{"name":85,"class":59},"Hospital Universitari de Bellvitge",60,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100370878","axillary-management-in-breast-cancer-patients-with-needle-biopsy-proven-nodal-metastases-after-neoadjuvant-chemotherapy-100370878","NCT04109079","Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy","ATNEC - Axillary Management in T1-3N1M0 Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases at Presentation After Neoadjuvant Chemotherapy","ATNEC","Inclusion Criteria:\n\n* Age ≥ 18\n* Male or female\n* cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition (see Section 6.4.1)\n\n  o Patients with occult primary invasive breast cancer (no identifiable invasive cancer in the breast) with FNA or core biopsy proven nodal metastases are eligible for the study.\n* FNA or core biopsy confirmed axillary nodal metastases at presentation\n* Oestrogen receptor and HER2 status evaluated on primary tumour\n* Received standard NACT as per local guidelines (Patients undergoing neoadjuvant endocrine therapy as part of another clinical trial are eligible)\n* Imaging of the axilla, as required, to assess response to NACT (per local guidelines)\n* Undergo a dual tracer sentinel node biopsy (SNB) after NACT with at least 3 nodes removed.\n\n  * If a single tracer SNB is performed: the patient is eligible only if the involved node is marked before or during NACT, and at least 3 nodes (including the marked node) are removed during sentinel node biopsy.\n  * If the node is not marked or the marked node is not removed: the patient is eligible only if the histology report shows evidence of down-staging with complete pathological response e.g., fibrosis or scarring in at least one node and at least 3 nodes removed.\n  * If fewer than 3 nodes are found on histology: the patient is eligible only if BOTH points a) and b), below, are met:\n\n    1. involved node was marked and removed during SNB; and\n    2. removed marked node shows evidence of downstaging on histology e.g. fibrosis or scarring.\n* If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if at least 3 nodes are removed.\n* No evidence of nodal metastases post NACT (isolated tumour cells, micro or macro metastasis)\n* Patients with complete pathological response in the axilla but residual disease in the breast post NACT are eligible for the study\n* Patients who are cN0 (node negative) at initial presentation, with a negative sentinel node post NACT showing evidence of treatment response or downstaging will be eligible, provided at least 3 nodes are removed.\n\n5.2. Exclusion Criteria\n\nParticipants will be excluded if they have any one of the following:\n\n* Bilateral synchronous invasive breast cancer\n* Sentinel node biopsy prior to NACT\n* Previous axillary nodal surgery on the same body side as the scheduled targeted sampling\n* Any previous cancer within last 5 years or concomitant malignancy except\n\n  * basal or squamous cell carcinoma of the skin\n  * in situ carcinoma of the cervix\n  * in situ or stage 1 melanoma\n  * contra- or ipsilateral in situ breast cancer\n  * chronic lymphocytic leukaemia not on treatment",{"count":96,"type":22},1900,[25],"The aim of this study is to assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no residual cancer in the lymph nodes on sentinel node biopsy, is non-inferior to axillary treatment in terms of disease free survival (DFS) and results in reduced risk of lymphoedema at 5 years.",[28,31,100],"Neoplasm, Breast",[102,103,104,105,106,107,108,109,110,111,112],"neoadjuvant chemotherapy","sentinel node biopsy","breast cancer","tattooing node","marking node","clip node","axillary ultrasound","node positive","axillary lymph node dissection","axillary radiotherapy","axillary treatment","2026-03-27",{"date":115,"type":52},"2026-03-30",{"date":117,"type":52},"2021-02-26",{"date":119,"type":22},"2030-02-28",{"name":121,"class":59},"University Hospitals of Derby and Burton NHS Foundation Trust",98,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":152},"100368161","phase-3-sentinel-node-biopsy-in-endometrial-cancer-100368161","NCT04073706","Sentinel Node Biopsy in Endometrial Cancer","A Phase III Randomised Clinical Trial Comparing Sentinel Node Biopsy With No Retroperitoneal Node Dissection in Apparent Early-Stage Endometrial Cancer","ENDO-3","Inclusion Criteria:\n\n1. Females, over 18 years, with histologically confirmed primary epithelial cancer of the endometrium of any cell type or uterine carcinosarcoma (mixed malignant mullerian tumour);\n2. Clinically stage I disease (disease confined to body of uterus);\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n4. Signed written informed consent;\n5. Participant must meet criteria for a laparoscopic or robotic surgical approach as determined by the treating physician (e.g. suitable for TH BSO, ability to tolerate Trendelenberg positioning)\n6. All available clinical evidence (physical examination findings, or medical imaging such as CT, MRI or ultrasound) demonstrates no evidence of extrauterine disease\n7. Myometrial Invasion on MRI of not more than 50%. (Only if participant is \\\u003C45yo, has ONLY Grade 1 EAC and wishes to retain their ovaries).\n8. Negative (serum or urine) pregnancy test ≤ 30 days of surgery in pre-menopausal women and women \\\u003C 2 years after the onset of menopause.\n\nExclusion Criteria:\n\n1. Evidence of extrauterine disease (apparent involvement of cervix, vagina, parametria, adnexa, lymph nodes, bladder, bowel or distant sites) by clinical examination and\u002For through medical imaging.\n2. Enlarged retroperitoneal pelvic and\u002For aortic lymph nodes (\\>1 cm) on medical imaging;\n3. Estimated life expectancy of less than 6 months;\n4. Patients who have absolute contraindications for adjuvant radiotherapy and\u002For chemotherapy;\n5. Patients who have previously received radiation treatment to the pelvis\n6. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);\n7. Patient compliance and geographic proximity that do not allow adequate follow-up;\n8. Patients with allergy to Indocyanine Green (ICG)\n9. Patients who have had previous retroperitoneal surgery\n10. Patients who require a retroperitoneal (pelvic +\u002F- para-aortic) lymph node dissection (lymphadenectomy)\n11. Other prior malignancies \\\u003C5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma of the breast insitu\n12. Uterine perforation during endometrial tissue sampling","FEMALE",{"count":133,"type":22},760,[135],"PHASE3","Endometrial cancer (EC) is the most common gynaecological cancer. Current treatment of EC typically includes removal of the uterus and to determine the extent of the disease (removal of fallopian tubes, ovaries \\& if required a lymph node dissection (surgical staging)). While lymph node dissection may be valuable to guide the need for adjuvant treatment (chemo or radiotherapy) after surgery, it has been a topic of controversy for the last 30 years. In some patients it causes morbidity, specifically lymphoedema. This recently has been replaced with sentinel node biopsy (SNB). It requires an injection of a dye into the cervix with specific equipment \\& surgical dissection of the lymph node in which the dye first becomes visible. Despite this promising proposition \\& similar to a lymph node dissection, the value to patients, cost effectiveness \\& potential harms (e.g. lymphedema) of SNB compared to no-node dissection in EC has never been established. Aim: determine the value of SNB for patients, the healthcare system and exclude detriment to patients using a randomised approach 1:1. Stage 1 - 444 patients. Stage 2 additional 316 patients.\n\nPrimary Outcome Stage 1:\n\nProportion of participants returning to usual daily activities at 12 months from surgery using the EQ-5D which will determine when women in both groups can return to their usual activities.\n\nPrimary Outcome Stage 2:\n\nTreatment non-inferiority as evaluated by disease-free survival status at 4.5 years post-surgery, as measured by the time interval between the date of randomisation and date of first recurrence. Confirmation of recurrent disease will be ascertained through clinical assessment, radiological work-up and\u002For histological results.",[138,31,139],"Endometrial Cancer Stage I","Surgery",[141,103],"uterine cancer","2026-01-28",{"date":144,"type":52},"2026-01-30",{"date":146,"type":52},"2021-01-18",{"date":148,"type":22},"2031-02",{"name":150,"class":151},"Queensland Centre for Gynaecological Cancer","OTHER_GOV",19,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},"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",{"count":162,"type":22},90,[25],"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.",[28,29,30,31,32,33,34,35,36,166],"Mastectomy",[38,39,41,166,43,45,44,42,47],"2026-01-15",{"date":170,"type":52},"2026-01-23",{"date":172,"type":52},"2022-08-22",{"date":174,"type":22},"2026-06",{"name":58,"class":59},2,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"100411375","refining-local-regional-therapy-for-ibc-100411375","NCT04636710","Refining Local-Regional Therapy for IBC","Refining Local-Regional Therapy for Inflammatory Breast Cancer (IBC)","Inclusion Criteria:\n\n* Stage III IBC (cT4d cN0-2). Inflammatory breast cancer is defined as the following constellation of symptoms (all of the following must be met):\n\n  * Rapid onset symptoms (6 months or less from time of diagnosis)\n  * Breast erythema, edema and\u002For peau d'orange and\u002For warm breast with or without an underlying palpable mass\n  * Erythema occupying at least one-third of the breast\n  * Pathologic confirmation (biopsy-proven) invasive breast carcinoma\n* Women age ≥18 years\n* ECOG performance status ≤2\n* Ability to understand and willingness to sign informed consent document and comply with study procedures, including baseline research biopsy. If the research biopsy is not felt to be reasonably safe or feasible, a waiver must be obtained from the Principal Investigator. A formal exception would not be required in this case.\n\nExclusion Criteria:\n\n* Participants who initiated pre-operative\u002Fneoadjuvant therapy prior to registration are ineligible.\n* Participants with Stage IV (metastatic) breast cancer are excluded. The absence of any evidence of distant disease on staging studies needs to be confirmed at the time of diagnosis (within 42 days from initial presentation) using the staging studies that are standard for the participating institution.\n* Participants with positive contralateral axillary nodes identified on standard imaging studies (MMG, MRI, US) are excluded. In participants with clinically suspicious axillary nodes, US guided biopsy will be performed prior to registration. If the contralateral axillary biopsy is positive, patients will not be eligible. If standard imaging does not identify contralateral disease yet drainage to the contralateral axillary basin is identified on pre-NAC lymphoscintigraphy, contralateral axillary US (if not already performed) will be obtained and any suspicious contralateral axillary nodes will undergo US guided biopsy. If the contralateral axillary biopsy is positive, patients will not continue on study for the evaluation of the primary endpoint, but their data will be used for the descriptive analyses of lymphatic drainage patterns in IBC. Contralateral invasive breast cancer without axillary involvement or in-situ carcinoma in either breast is allowed.",{"count":185,"type":22},50,[25],"This Feasibility study is trying to determine:\n\n* If Lymphoscintigraphy (imaging of the lymphatic drainage patterns) is effective in demonstrating the drainage to the sentinel lymph nodes in patients with inflammatory breast cancer.\n* The likelihood of identifying the sentinel lymph nodes in the operating room, using both blue dye and the radioactive substance used for lymphoscintigraphy.\n* The incidence of lymphedema (arm swelling which occurs after lymph node surgery) in women with inflammatory breast cancer\n* Outcomes for women with inflammatory breast cancer, whether or not the sentinel lymph nodes can be identified.",[28,189,31],"Inflammatory Breast Cancer",[28,189,31],"2025-12-22",{"date":193,"type":52},"2025-12-29",{"date":195,"type":52},"2021-06-02",{"date":197,"type":22},"2028-12-01",{"name":199,"class":59},"Dana-Farber Cancer Institute",1,{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":200},"100616255","phase-3-the-value-of-indocyanine-green-guided-near-infrared-fluorescence-technology-in-tracing-sentinel-lymph-nodes-during-esophagectomy-100616255","NCT07303231","The Value of Indocyanine Green-guided Near-infrared Fluorescence Technology in Tracing Sentinel Lymph Nodes During Esophagectomy","The Value of Indocyanine Green-guided Near-infrared Fluorescence Technology in Tracing Sentinel Lymph Nodes During Esophagectomy: A Multicenter Prospective Cohort Study","Inclusion Criteria:\n\n1. Age and gender: 18-75 years old, male and female unlimited;\n2. Preoperative biopsy was pathologically diagnosed as esophageal squamous cell carcinoma;\n3. Preoperative combination with neoadjuvant chemoradiotherapy;\n4. Surgical resection of esophageal carcinoma under endoscopic selection and intraoperative anastomosis;\n5. Heart, lung, liver and kidney functions can tolerate operation;\n6. Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent.\n\nExclusion Criteria:\n\n1. Allergic to ICG or iodine;\n2. Patients with a history of chest surgery or thoracic lymph node dissection;\n3. Patients needing emergency surgery;\n4. Patients whose tumors involve neighboring organs and need to be removed by combining organs;\n5. Patients with tumor recurrence or distant metastasis;\n6. Patients who had participated in or were participating in other clinical trials within the previous 4 weeks were included;\n7. A history of serious mental illness;\n8. Pregnant or lactating women;\n9. Patients with other conditions considered by the researcher should not participate in the study.","75 Years",{"count":210,"type":22},144,[135],"Sentinel lymph nodes, as the primary site of tumor metastasis, play a pivotal role in assessing patient prognosis and planning subsequent treatment strategies. The investigators plan to conduct a multicenter, prospective cohort study to evaluate the effectiveness of indocyanine green (ICG)-guided near-infrared imaging in tracing sentinel lymph node during esophageal squamous cell carcinoma (ESCC) surgery, compared with the gold standard of complete lymph node dissection (CLND), in detecting metastatic disease. This study aims to address the following core questions:\n\n1. In ESCC patients undergoing surgery, can sentinel lymph node biopsy reduce unnecessary lymph node dissection?\n2. In ESCC patients undergoing surgery, can reducing lymph node dissection decrease postoperative complications such as chylothorax and weakened immunity? During the study, ICG will be injected around the tumor under intraoperative gastroscopy guidance, followed by tracking of fluorescent lymph nodes using a thoracoscopic near-infrared camera. Professional thoracic surgeons will group and mark these lymph nodes for intraoperative frozen pathology. Subsequent CLND and routine postoperative pathology will be performed. This study will collect patients' clinical information, ICG imaging results, pathological examination results, and other data for statistical analysis to assess the sensitivity and negative predictive value (NPV) of the ICG imaging system. If the study results support the effectiveness of the ICG imaging system, it has the potential to become an important tool for sentinel lymph node localization and biopsy in future ESCC surgeries, helping to reduce unnecessary lymph node resection and improve surgical efficiency and safety.\n\nParticipants will:\n\n1. Undergo minimally invasive ESCC surgery within 2 weeks of enrollment, including the 14th day.\n2. Receive ICG injection around the tumor under intraoperative gastroscopy guidance during surgery.\n3. Have perioperative, postoperative pathology, and complication information recorded.\n4. Undergo standardized follow-up after surgery.",[214,31,215,216],"Esophageal Cancer","Lymphadenectomy","Indocyanine Green","NOT_YET_RECRUITING","2025-12-11",{"date":220,"type":52},"2025-12-24",{"date":222,"type":22},"2026-01-01",{"date":224,"type":22},"2028-02-01",{"name":226,"class":59},"Fujian Medical University Union Hospital",{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":250,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":200},"100566245","sentinel-node-and-organ-sparing-surgery-in-stage-i-colon-carcinoma-100566245","NCT06652672","Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma","Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma (SENTRY Trial)","SENTRY","Inclusion Criteria:\n\n* Oral and written informed consent (IC)\n* Aged 18 years and older\n* Fit for both organ-sparing surgery and colectomy\n* Pathologically confirmed T1-2 adenocarcinoma of the colon following R0, R1, or Rx endoscopic resection with an estimated LNM risk \\>15% (Table 5.2.2. in module 5.2 of the Dutch CRC guideline); or a lesion macroscopically suspected to be (deep-invasive) T1 colon cancer, measuring \\\u003C40 mm, for which wedge resection is considered the most suitable local resection technique as recommended by the MDT\n* The resection scar after local excision is expected to be clearly recognized at endoscopy, either by a tattoo or by detecting a scar in the colorectal segment where no other polypectomies were performed\n* Lesion located \\>25cm from the anus based on endoscopic measurement, or above sigmoid take-off\n\nExclusion Criteria:\n\n* Patients who opt for active follow-up instead of surgery following shared decision-making\n* Distant metastasis\n* Lynch syndrome\n* Another active malignancy requiring palliative treatment at the time of colon cancer diagnosis\n* Previous colorectal cancer within the last 5 years\n* Tumours that comprised \\>50% of the colon circumference before resection\n* Tumours involving the ileocaecal valve\n* Pregnancy, lactation or a planned pregnancy during the course of the study\n* Known allergy to any of the compounds used for SLN identification (ICG, Iodine or Sodium iodide)\n* Previous colonic surgery (excluding appendectomy)\n* Contra-indication for laparoscopic or robotic surgery\n* Severe kidney- or liver failure\n* Hyperthyroidism or an autonomously functioning thyroid adenoma",{"count":236,"type":22},341,[25],"The aim of this study is to reduce the need for colectomy and its' associated morbidity and mortality in patients with pT1-2 colon carcinoma after endoscopic resection and an estimated lymph node metastasis (LNM) risk of \\>15%, or with macroscopically suspected T1 tumors, by performing an endoscopic-assisted laparoscopic\u002Frobotic wedge resection of the tumor or scar, along with sentinel node (SLN) biopsy using indocyanine green (ICG). This intervention will be compared to the standard-of-care segmental resection using a partially randomized patient preference design. The primary outcome is the 3-year recurrence rate.",[240,241,31,242,243,244,245,246,247,248,249,34],"Colon Cancer","Colon Adenocarcinoma","Sentinel Lymph Node Biopsy","Colon Neoplasms","Colon Neoplasm","Fluorescence","Fluorescence Guided Surgery","Fluorescence Laparoscopy","Fluorescence-guided Resection","Colon Surgery",[251,245,252,253,254,255,256],"Colon cancer","Sentinel lymph node","Indocyanine green (ICG)","Organ sparing surgery","Organ preserving surgery","Local resection","2025-11-17",{"date":259,"type":52},"2025-11-20",{"date":261,"type":52},"2024-12-12",{"date":263,"type":22},"2032-12-12",{"name":265,"class":59},"Meander Medical Center",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":278,"conditions":279,"keywords":280,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":200},"100293263","phase-1-bronchial-nir-image-guided-resection-100293263","NCT03097575","Bronchial NIR Image-guided Resection","Bronchial NIR Image-guided Resection, Mapping And Targeted Lymphadenectomy for Lung Lesions","Inclusion Criteria:\n\n* Patients that have agreed to undergo video assisted thoracoscopic surgery or thoracotomy for surgical resection as recommended by their thoracic surgeon.\n* 18 years of age or older\n* Documented, signed, dated informed consent obtained prior to any study specific procedures being performed\n\nExclusion Criteria:\n\n* Pregnant women are excluded and women of childbearing potential without a negative pregnancy test prior to study procedures. All patients with Iodine allergies will be excluded.",{"count":274,"type":22},100,[276,277],"PHASE1","PHASE2","This is a clinical trial to evaluate the use of peritumoral injection of near-infrared dye indocyanine green to identify lung lesions and sentinel lymph nodes. The primary purpose is to determine if the use of ICG injected via navigational bronchoscopy, CT-guided or transthoracic allows us to identify the first lymph node that drains from the tumor, and thus would be the most likely site for metastatic disease, and remove it for analysis to improve the ability to detect tumor in this node and to remove this additional site that potentially contains tumor cells. Using this intraoperative imaging technique, we aim to improve the identification of lung nodules for resection and the intraoperative identification of sentinel lymph nodes in the event that a lymphadenectomy is performed.",[31],[281,282,283,215],"Lung lesions","Navigational bronchoscopy","Near infrared imaging","2025-11-05",{"date":286,"type":52},"2025-11-10",{"date":288,"type":52},"2015-01-06",{"date":290,"type":22},"2029-01-01",{"name":292,"class":59},"Massachusetts General Hospital",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":300,"targetDuration":302,"studyType":303,"phases":4,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":176},"100497929","tad-after-chemotherapy-in-locally-advanced-breast-cancer-100497929","NCT05763641","TAD After Chemotherapy in Locally Advanced Breast Cancer","Target Axillary Dissection After Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer","Inclusion Criteria:\n\n* Axillary lymph node metastasis proven by cytology\n* Clinical or radiological N2a (at least 4 suspicious lymph nodes on axillary ultrasound at diagnosis)\n* Extensive T4 subsidiary to axillary lymphadenectomy according to current clinical criteria\n* Neoadjuvant chemotherapy\n\nExclusion Criteria:\n\n* cN3 verified by imaging tests\n* N2 due to internal mammary involvement (N2b).\n* Tumors whose surrogate molecular subtype is luminal A.\n* Patients undergoing neoadjuvant endocrine therapy\n* Patients with local recurrences and metastatic tumors.",{"count":301,"type":22},162,"3 Years","OBSERVATIONAL","This is an observational study to validate target axillary dissection (TAD) in locally advanced tumors (cN2 and\u002For cT4).",[31,28,306],"Locally Advanced","2025-09-08",{"date":309,"type":52},"2025-09-10",{"date":311,"type":52},"2021-02-01",{"date":313,"type":22},"2026-06-01",{"name":85,"class":59},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":208,"enrollmentInfo":322,"targetDuration":4,"studyType":303,"phases":4,"briefSummary":323,"conditions":324,"keywords":327,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":200},"100604826","rapid-assessment-of-sentinel-lymph-node-metastasis-status-using-a-pan-ck-targeting-nir-ii-fluorescent-probe-in-breast-cancer-100604826","NCT07154563","Rapid Assessment of Sentinel Lymph Node Metastasis Status Using a Pan-CK-targeting NIR-II Fluorescent Probe in Breast Cancer","NIR-II","Inclusion Criteria:\n\n* Adult patients between 18-75 years of age\n* Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment\n* Breast cancer patients who are scheduled to undergo sentinel lymph node biopsy or axillary lymph node dissection;\n* Good operative candidate\n* Subject capable of giving informed consent and participating in the process of consent\n\nExclusion Criteria:\n\n* Patients unable to participate in the consent process\n* Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc",{"count":86,"type":22},"Breast malignant tumors are a serious threat to women's health, and the current treatment for breast malignant tumors is still dominated by surgery, but the problems faced by patients after surgery such as edema and tumor recurrence are still relatively common, and the high recurrence rate and the occurrence of postoperative complications are closely related to the removal of metastatic lymph nodes during surgery. Therefore, accurate assessment of sentinel lymph node (SLN) metastases is essential to determine the extent of axillary lymph node dissection (ALND) and minimize complications. In this study, we developed a new technique that can rapidly distinguish between metastatic lymph nodes and normal sentinel lymph nodes (SLNs) in breast cancer patients. Briefly, fresh tissue is incubated with the probe and imaged immediately after intraoperative sentinel lymph node resection to identify the metastatic status of SLN. The accuracy of fluorescence imaging is confirmed by pathological diagnosis.",[325,31,29,326],"Breast Cancer Metastatic","Metastasis",[320,28,31,326],"2025-08-27",{"date":330,"type":52},"2025-09-04",{"date":332,"type":52},"2025-02-01",{"date":334,"type":22},"2026-12-01",{"name":336,"class":59},"Yunnan Cancer Hospital",{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":345,"enrollmentInfo":346,"targetDuration":4,"studyType":23,"phases":348,"briefSummary":349,"conditions":350,"keywords":355,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":372},"100498763","sentinel-node-biopsy-versus-limited-elective-neck-dissection-in-early-cancers-of-oral-cavity-node-negative-100498763","NCT05774483","Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative","Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative (SECOND N0): Non-inferiority Phase III Trial","SECOND N0","Inclusion Criteria:\n\n1. Age \\>18 years of age\n2. Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa\n3. T1 and T2 lesions as per AJCC TNM 8 edition\n4. Clinicoradiologically node negative\n5. Amenable to per oral excision\n6. Treatment naïve\n7. No other site of malignancy\n\nExclusion Criteria:\n\n1. Previous surgery in the head and neck region,\n2. Upper alveolar or palatal lesions\n3. Large heterogeneous leukoplakia or other premalignant lesions\n4. Previous malignancy in the head and neck region\n5. Patients requiring the free flap reconstruction","80 Years",{"count":347,"type":22},508,[25],"The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers.\n\nThe main questions it aims to answer are:\n\n* Survival outcomes\n* Morbidity outcomes\n* Cost-effectiveness\n\nParticipants will either undergo sentinel node biopsy followed by completion neck dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck dissection where level IIb will be cleared only if level IIa is metastatic (limited END). The study will compare the outcomes in the two cohorts.",[351,352,353,354,242,29,31],"Mouth Neoplasms","Oral Cancers","Oral Squamous Cell Carcinoma (OSCC)","Oral Squamous Cell Carcinomas",[356,357,358,359,360,361,362],"mouth neoplasms","neck dissection","sentinel lymph node biopsy","survival","morbidity","oral cancers","oral squamous cell carcinoma","2025-07-14",{"date":365,"type":52},"2025-07-17",{"date":367,"type":52},"2025-04-16",{"date":369,"type":22},"2034-04",{"name":371,"class":151},"Tata Memorial Hospital",3,{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":208,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":381,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":176},"100596069","comparison-of-two-position-and-four-position-cervical-injection-techniques-for-sentinel-lymph-node-mapping-in-endometrial-cancer-using-methylene-blue-100596069","NCT07040657","Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue","Comparison of Two-Point and Four-Point Cervical Injection Techniques Using Methylene Blue for Sentinel Lymph Node Mapping in Endometrial Cancer","Inclusion Criteria:\n\n* Individuals diagnosed with stage I endometrial cancer based on CT and PET-CT imaging.\n* Individuals with a pathologically confirmed diagnosis of stage I endometrial cancer.\n\nExclusion Criteria:\n\nMedical Conditions\n\n* Individuals diagnosed with dementia.\n* Individuals with allergies to methylene blue or iodine.\n* Individuals who have received active treatment for another malignancy within the past five years.\n* Inability to successfully perform PLD (pelvic lymphadenectomy) or history of prior PLD.\n* Women with multiple and confluent lymph nodes identified as positive on FDG-PET\u002FCT (such cases are not considered stage I).\n\nCancer-Related Conditions\n\n* Individuals with clinically or radiologically identified positive lymph nodes or metastatic disease.\n* Individuals with a history of pelvic dissection and\u002For radiation therapy.\n* Individuals with advanced cervical or uterine cancer.\n* Individuals with T3\u002FT4 lesions.\n* Individuals with cervical tumors larger than 2 cm.\n\nOrgan Dysfunction\n\n• Individuals with hepatic dysfunction and a MELD score ≥ 10 and creatinine ≥ 2·0 mg\u002Fdl patients.",{"count":274,"type":22},[25],"This clinical trial evaluates lymph node mapping in newly diagnosed endometrial cancer patients undergoing surgery. The standard technique uses a 2-point methylene blue cervical injection. The study aims to determine if increasing injection points improves mapping success.",[384,138,31,326],"Endometrial Neoplasms",[386,387,388,389],"endometrial neoplasm","methylene blue","metastasis","cervix","2025-06-18",{"date":392,"type":52},"2025-06-27",{"date":394,"type":52},"2025-05-01",{"date":396,"type":22},"2026-11-01",{"name":398,"class":59},"Dokuz Eylul University",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":208,"enrollmentInfo":405,"targetDuration":4,"studyType":303,"phases":4,"briefSummary":407,"conditions":408,"keywords":412,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":200},"100594366","epcam-targeted-surface-enhanced-raman-spectroscopy-nanotags-for-rapid-evaluation-of-surgical-margins-and-sentinel-lymph-node-metastasis-status-in-breast-cancers-100594366","NCT07018505","EpCAM-Targeted Surface-Enhanced Raman Spectroscopy Nanotags for Rapid Evaluation of Surgical Margins and Sentinel Lymph Node Metastasis Status in Breast Cancers","Inclusion Criteria:\n\n* Adult patients between 18-75 years of age\n* Female\n* Patients presenting with a breast cancer to be resectable on pre-operative assessment\n* Good operative candidate\n* Subject capable of giving informed consent and participating in the process of consent\n\nExclusion Criteria:\n\n* Patients unable to participate in the consent process\n* Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc\n* Other conditions that the researcher considers inappropriate to participate in the study",{"count":406,"type":22},40,"For early breast cancer patients, breast-conserving surgery and sentinel lymph node biopsy have emerged as the cornerstone of precision oncology, harmonizing oncologic efficacy with the preservation of breast cosmetics and axillary function. However, conventional margin evaluation relies on subjective experience, leading to positive margin rates of 15%-50% Additionally, sentinel lymph node biopsy faces inherent technical limitations, including prolonged procedural time and significant false-negative rates in detecting micro-metastases. To overcome these challenges, the investigators will introduce a stable \"sandwich\" EpCAM-targeted surface-enhanced Raman spectroscopy (SERS) detection system to provide rapid evaluation of surgical margins and sentinel lymph node (SLN) metastasis status. In brief, a portion of resected tissue will be immediately homogenized by grinding, and the tissue homogenate will then be analyzed using this detection system to determine its histological characteristics. Pathological confirmation will further validate the method. This approach aims to improve the accuracy and efficiency of intraoperative assessment of breast-conserving surgical margins and SLN status, thereby effectively reducing local recurrence rates and complications.",[31,409,410,411],"Breast Cancers","Metastases","Margin Assessment",[31,413,414,415,416],"Surface Enhanced Raman Spectroscopy","EpCAM","Breast cancers","Surgical margin","2025-06-04",{"date":419,"type":52},"2025-06-12",{"date":421,"type":22},"2025-06-15",{"date":423,"type":22},"2026-07-01",{"name":336,"class":59},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":4,"enrollmentInfo":433,"targetDuration":4,"studyType":23,"phases":435,"briefSummary":436,"conditions":437,"keywords":440,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":200},"100586142","application-of-endoscell-intraoperative-cellular-probing-technology-for-early-stage-breast-cancer-100586142","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",{"count":434,"type":22},709,[25],"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.",[28,31,438,439],"Frozen Section","Cytology",[441,442,443,444,445],"Breast carcinoma","sentinel lymph node","tracer","touch imprint cytology","epifluorescence widefield microscope system","2025-03-28",{"date":448,"type":52},"2025-04-04",{"date":450,"type":52},"2024-01-30",{"date":452,"type":22},"2025-12-31",{"name":454,"class":59},"Fudan University",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":462,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":465,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":200},"100472860","peritumoral-microbubbles-and-ceus-for-sln-detection-and-biopsy-in-hnscc-100472860","NCT05437380","Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC","The Value of Peritumoral Microbubbles and Contrast-enhanced Ultrasonography to Detect and Biopsy Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Aged 18-70;\n* Pathological biopsy indicated head and neck squamous cell carcinoma;\n* MR\u002FCT examination indicate no suspected cervical lymph node metastasis;\n* The patient intent to perform primary focal resection and unilateral\u002Fbilateral neck dissection at our center;\n* agree to participate in clinical trials and sign informed consent.\n\nExclusion Criteria:\n\n* allergic to microbubbles contrast agents;\n* patients who cannot tolerate surgery;\n* enlarged cervical lymph node in palpation or suspected cervical lymph node metastasis indicated in MR\u002FCT examination;\n* distant metastasis.","70 Years",{"count":464,"type":22},70,[25],"Head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Cervical lymph node metastasis is frequently encounted on the date of diagnosis. Surgical resection is one of the most important treatment methods for head and neck squamous cell carcinoma with or without lymph node metastasis. At present, for cN0 patients, prophylactic neck dissection is recommended for squamous cell carcinoma originating in suprglottic, hypopharyngeal and oropharyngeal areas et al. Related studies reported that less than 30% of patients with cN0 were confirmed to have lymph node metastasis in postoperative pathological examination, who underwent neck dissection. Unnecessary neck dissection may increase complication incidence, such as neurovascular injury, chylous leakage, sialosyrinx. Accurate preoperative assessment is helpful to reduce unnecessary neck dissection. Sentinel lymph node biopsy were proved to be effective in reducing prophylactic lymph node dissection in breast cancer, melanoma and other malignant tumors. Compared with γ probe detection and indolyanine green injection, microbubble and contrast-enhanced ultrasound has no radiation and disturbance to resection margins in sentinel lymph nodes detection. Furthermore, surgeons could conduct lymph node puncture biopsy simultaneously under ultrasound guidance, which can further minimize surgical trauma. At present, the role of microbubble and contrast-enhanced ultrasound in sentinel lymph node detection and biopsy is rarely reported in head and neck squamous cell carcinoma. This study aims to explore the accuracy of peritumoral microbubbles and contrast-enhanced ultrasound for sentinel lymph nodes biopsy in predicting cervical lymph node metastasis in head and neck squamous cell carcinoma.",[31,468],"Head and Neck Squamous Cell Carcinoma","2025-03-20",{"date":471,"type":52},"2025-03-25",{"date":473,"type":52},"2022-09-20",{"date":475,"type":22},"2026-06-28",{"name":477,"class":59},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":494,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":372},"100414047","targeted-axillary-dissection-tad-in-early-stage-node-positive-breast-cancer-100414047","NCT04671511","Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer","Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla","TADEN","Inclusion Criteria:\n\n* Participants must be ≥ 18 years old.\n* Participants with a clinical T1 or T2 invasive ductal or lobular breast carcinoma, regardless of estrogen\u002Fprogesterone\u002Fhuman epidermal growth factor receptor 2 (HER2) receptor status.\n* Participants with clinical (on palpation) N0 and up to two suspicious lymph nodes on axillary ultrasound.\n* Participant with biopsy-proven positive axillary disease made by core needle biopsy or fine-needle aspiration.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status less than 2.\n* Participants must understand, accept, and have signed the approved consent form.\n\nExclusion Criteria:\n\n* Participant with previous ipsilateral axillary surgery, including sentinel lymph node biopsy.\n* Participants with distant metastases.\n* Participants that have had previous radiotherapy to the axillary nodes.\n* Participants who received neoadjuvant therapy.\n* If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, patent blue, methylene blue or radiocolloid dye.\n* Participants who are unable to provide informed consent.",{"count":122,"type":22},[25],"RATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population.\n\nPURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.",[490,491,492,493,31],"Breast Cancer Female","Early-stage Breast Cancer","Lymph Node Metastases","Axillary Metastases",[104,495,358,496,497],"targeted axillary dissection","clinically negative axilla","metastatic axillary lymph nodes","2025-02-18",{"date":500,"type":52},"2025-02-20",{"date":502,"type":52},"2021-03-30",{"date":504,"type":22},"2026-07",{"name":506,"class":59},"Jewish General Hospital",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":514,"briefSummary":515,"conditions":516,"keywords":519,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":4},"100573033","correlation-of-pelvic-sentinel-lymph-node-with-superficial-vein-100573033","NCT06741007","Correlation of Pelvic Sentinel Lymph Node With Superficial Vein","Inclusion Criteria:\n\n* all women with early stage endometrial cancer who will be operated for staging\n\nExclusion Criteria:\n\nPrevious radiotheraphy Previous pelvic retropelvic LN dissection Women with any disease that precludes pelvic retropelvic LN dissection (such as peritoneal dialysis)\n\n\\-",{"count":274,"type":22},[25],"Pelvic Sentinel Lymph Node (SLN) biopsy is an important integral part of endometrial surgery. Although SLN is usually found on internal iliac artery, location is variable. Lymphatic pathways in pelvis determines the location (Obturator, internal iliac or external iliac vessel locations). Since it is accepted that the lymphatic channel formation during embryologic life follows venous system formation investigators hypothesized that the presence or absence of superior or deep uterine vein may determine the location of sentinel lymph node",[31,517,518],"Superficial Uterine Vein","Deep Uterine Vein",[442,520,521],"uterine vein","uterine artery","2024-12-15",{"date":524,"type":52},"2024-12-18",{"date":526,"type":22},"2024-12-22",{"date":528,"type":22},"2026-09-15",{"name":530,"class":59},"Istanbul University",{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":535,"acronym":320,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":208,"enrollmentInfo":537,"targetDuration":4,"studyType":303,"phases":4,"briefSummary":538,"conditions":539,"keywords":540,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":200},"100570893","tumor-targeted-nir-ii-fluorescent-molecular-probes-for-the-identification-of-breast-cancer-tissue-and-sln-metastatic-status-100570893","NCT06713161","Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status","Inclusion Criteria:\n\n* Adult patients between 18-75 years of age\n* Female\n* Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment\n* Good operative candidate\n* Subject capable of giving informed consent and participating in the process of consent\n\nExclusion Criteria:\n\n* Patients unable to participate in the consent process\n* Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc\n* Other conditions that the researcher considers inappropriate to participate in the study",{"count":406,"type":22},"Accurate evaluation of tumor boundaries in breast-conserving surgery is closely associated with reducing the second operation of patients. Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Near-infrared-II (NIR-II) fluorescence imaging using molecular agents has shown promise for in situ imaging during resection. However, very effective probes can be applied to clinical trials up to now, which limits the clinical application of fluorescence imaging. Here we developed a new technology that can quickly differentiation between cancer and para-cancer tissue as well as metastatic and normal sentinel lymph nodes(SLN). In brief, the fresh tissues were incubated with the probe immediately after intraoperative resection and imaged to identify the tumor area and distinguish the metastatic status of SLN. The accuracy of fluorescence imaging was confirmed by pathological diagnosis.",[28,31,410,411],[320,28,31,541,410],"Surgical Navigation","2024-11-27",{"date":544,"type":52},"2024-12-03",{"date":546,"type":52},"2024-09-01",{"date":548,"type":22},"2025-12-25",{"name":336,"class":59},{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":557,"enrollmentInfo":558,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":569,"locationsCount":200},"100510544","sentinel-lymph-node-biopsy-in-early-stage-ovarian-cancer-100510544","NCT05927818","Sentinel Lymph Node Biopsy in Early-Stage Ovarian Cancer","Efficacy of Sentinel Lymph Node Biopsy in Early-Stage Ovarian Cancer","Inclusion Criteria:\n\nMust have a suspicious adnexal mass for early stage ovarian cancer\n\nMust be medically and surgically fit enough to perform SLNB and complete the systematic lymphadenectomy.\n\n\\-\n\nExclusion Criteria:\n\nOvarian mass with low probability for early stage ovarian cancer.\n\nMedical or surgical contraindications for surgical comprehensive staging.\n\nMetastatic cancers or double primary cancers (metachronous) of ovary\n\nRecurrent ovarian cancer\n\nPreoperative or intraoperative finding of advanced ovarian cancer (FİGO stage III and IV)\n\nNeoadjuvant ovarian cancer\n\n\\-","90 Years",{"count":274,"type":22},[25],"The primary goal of this prospective study is to define the efficacy of the sentinel lymph node biopsy (SLNB) procedure by comparing it to the results obtained from systematic lymphadenectomy, each performed in participants with a suspicious adnexal mass for early-stage ovarian cancer.",[31,562],"Ovarian Carcinoma","2024-11-21",{"date":565,"type":52},"2024-11-25",{"date":567,"type":52},"2023-04-15",{"date":168,"type":22},{"name":530,"class":59},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":462,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":200},"100511108","omission-of-slnb-in-cn0-early-breast-cancer-100511108","NCT05935150","Omission of SLNB in CN0 Early Breast Cancer","Omission of Sentinel Lymph Node Biopsy (SLNB ) in Early Breast Cancer Patients with Clinically Assessed Negative Axillary Lymph Nodes (cN0): a Phase II, Prospective Clinical Trial","Inclusion Criteria:\n\n1. Female patients aged 18-70 years;\n2. Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery;\n3. Negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET);\n4. All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki-67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;\n5. Good compliance, normal comprehension and ability to receive treatment and follow-up as required;\n6. ECOG score 0-1;\n7. Patients volunteered for this study and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Bilateral\u002Flactating\u002Fpregnant breast cancer;\n2. Previous history of malignant tumor or neoplasm;\n3. Clinical or imaging confirmation of distant metastasis;\n4. History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;\n5. Prior history of radiotherapy to the breast or chest;\n6. Positive pathological margins after breast-conserving surgery or mastectomy;\n7. Severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection;\n8. Aspartate aminortransferse (AST) and Alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; left ventricular injection fraction (LVEF) \\\u003C 50% on cardiac ultrasound;\n9. Inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons;\n10. No personal freedom and independent civil capacity;\n11. Presence of mental disorders, addictions, etc;\n12. Not eligible for enrollmentas as judged by the investigator.",{"count":578,"type":22},311,[25],"The OMSLNB trial adopts a prospective, single-arm, non-inferiority, phase-II, open-label study design. Patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cN0 will be eligible for inclusion, enrolled patients are required to complete 2 or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, \\[18F\\]-FDG PET-MRI, eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery (BCS). So as to decrease the edema of upper arm, and finally improve the quality of life of the patients.",[28,582,31],"Clinically Assessed Negative Axillary Lymph Nodes",[104,584,358],"clinically assessed negative axillary lymph nodes","2024-10-11",{"date":587,"type":52},"2024-10-15",{"date":589,"type":52},"2023-06-21",{"date":591,"type":22},"2027-10-01",{"name":593,"class":59},"The First Affiliated Hospital with Nanjing Medical University",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":23,"phases":602,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":611,"locationsCount":200},"100345538","minimally-invasive-colon-cancer-surgery-through-immunomics-and-optical-mapping-of-the-sentinel-lymph-node-100345538","NCT03779009","Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.","MINIMAL","Inclusion Criteria:\n\n* Tumor type: proven adenocarcinoma of the colon\n* Extent of disease (AJCC 7th edition): clinically node negative (stage II) non-metastatic colon cancer\n* Locally resectable disease\n* Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent\n* Laboratory data\n\n  * Serum creatinine ≤ 1.5 mg\u002Fdl or a calculated GFR ≥ 60 mL\u002Fmin\u002F1.73 m2\n  * Serum total bilirubin ≤ 1.5 mg\u002Fdl, except for known Gilbert's disease\n  * Platelet count \\> 100,000\u002Fµl\n  * Hemoglobin \\> 9g\u002Fdl\n  * Neutrophil granulocytes \\> 1,500\u002Fml\n  * International Normalized Ratio (INR) ≤ 2\n* Absence of alcohol and\u002For drug abuse\n* No inclusion in other clinical trials interfering with the study protocol\n* No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy\n* Absence of any severe organ insufficiency\n* No pregnancy or breast feeding\n* Adequate contraception in fertile patients\n* Written informed consent\n\nExclusion Criteria:\n\n* Node positive and\u002For metastatic disease\n* Locally unresectable disease\n* Medically unfit patients (Karnofsky index \\\u003C 70%)\n* Allergies to any of the procedural substances (allergy to iodides, hypersensitivity to products containing human albumin)",{"count":464,"type":22},[25],"The project investigates the feasibility of laparoscopic fluorescent imaging for the intraoperative detection of the sentinel lymph node (SLN) in colon cancer patients. In addition, the topology of immunological and microenvironmental changes in normal and invaded lymph nodes (LN's) will be correlated to the LN location (anatomical mapping).",[240,31],"2024-09-03",{"date":607,"type":52},"2024-09-19",{"date":609,"type":52},"2018-03-01",{"date":452,"type":22},{"name":612,"class":59},"University Hospital, Ghent",{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":131,"minAge":620,"maxAge":345,"enrollmentInfo":621,"targetDuration":4,"studyType":23,"phases":623,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":630,"completionDateStruct":631,"leadSponsor":633,"locationsCount":200},"100536029","omission-of-axillary-surgery-in-breast-cancer-patients-100536029","NCT06259513","Omission of Axillary Surgery in Breast Cancer Patients","Feasibility of Tailoring Axillary Surgery Based on the Molecular Subtype and Nodal Burden of Breast Cancer Patients- SentiOMIT and SentiMACRO Trial","Inclusion Criteria:\n\n* female patients aged \\>\u002F=55 years old\n* unifocal cancer on imaging\n* breast tumour size based on imaging of \\\u003C\u002F=3cm\n* no evidence of axillary adenopathy on imaging\n* patients with strongly positive ER and PR and negative HER2 on biopsy\n* grade 1-2 tumour on core biopsy\n* patient who opt for mastectomy\n\nExclusion Criteria:\n\n* patients with T3\u002FT4 or stage IV disease, patients with preoperative known N+ disease, bilateral breast cancers, patients planned for neoadjuvant chemotherapy, patients with other malignancies.","21 Years",{"count":622,"type":22},350,[25],"The treatment and prognosis of breast cancer (BC) are dependent on its molecular subtype and nodal burden. In early BCs with favourable molecular subtype, the incidence of axillary node involvement is low. However, these patients are still subjected to an axillary operation, which can result in additional cost, operating time and morbidities. Similarly, in patients with limited nodal burden of 1-2 metastatic nodes, there is emerging evidence that these patients may need sentinel lymph node biopsy (SLNB) only, instead of an axillary clearance (AC), which has more surgical morbidities.\n\nWe aimed to determine if axillary surgery could be safely tailored in BC patients based on their molecular subtype and nodal burden, without compromising their oncological outcomes. This could in turn reduce the morbidities associated with the axillary surgery,\n\nTotal 350 patients will be enrolled. 50 patients with early BC and favourable molecular subtype will be enrolled in a pilot study A (SentiOMIT), whereby SLNB is omitted. For eligible patients who declined study A and other stage I-II patients, with preoperative N0 status, undergoing upfront surgery but did not meet the inclusion criteria of Study A, these patients will be enrolled into study B (SentiMACRO) to undergo SLNB.\n\nIn study B, the patients will be categorized based on SLNB into 3 groups with 100 patients in each arm: B1 with pN0, B2- 1-2 metastatic nodes and B3- \\>\u002F=3 metastatic nodes. In Study B, we aim to investigate if the B2 group (100 patients) can be treated with a less invasive procedure of SLNB alone instead of AC, without affecting oncological outcomes. B1 and B3 are controls.\n\nThe outcomes for study A and B include short term outcomes such as morbidity rates, cost and operating time savings. Long term outcomes include recurrence and survival rates. This study will allow individualisation of axillary surgery based on the patient's molecular subtype and nodal burden, to benefit patients' care.",[28,31,626],"Breast Neoplasms","2024-02-06",{"date":629,"type":52},"2024-02-14",{"date":627,"type":22},{"date":632,"type":22},"2033-12-31",{"name":634,"class":151},"KK Women's and Children's Hospital",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":641,"eligibilityCriteria":642,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":643,"targetDuration":4,"studyType":23,"phases":645,"briefSummary":646,"conditions":647,"keywords":648,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":200},"100529076","phase-2-sentinel-lymph-node-localisation-with-an-ultra-low-dose-of-magtrace-in-breast-cancer-patients-100529076","NCT06169072","Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients","Sentinel Lymph Node Localisation With an Ultra-low Dose of Superparamagnetic Iron Oxide Nanoparticles in Patients With Breast Cancer","MagSnow2","Inclusion Criteria:\n\n* Planned for sentinel lymph node biopsy at (or after) breast surgery\n* Signed and dated written informed consent before the start of specific protocol procedures\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding\n* Iron overload disease\n* Known hypersensitivity to iron, dextran compounds or blue dye.\n* Inability to understand given information and give informed consent or undergo study procedures",{"count":644,"type":22},220,[277],"The overall aim is to demonstrate that the use of superparamagnetic iron oxide nanoparticles (SPIO) as a tracer in an ultra-low dose (0.1 ml) is non-inferior for sentinel lymph node (SLN) detection in patients with breast cancer compared to the dual technique using Tc99m +\u002F- blue dye, and to evaluate MRI breast artefacts and skin staining over time.",[28,31],[38,242],"2024-01-25",{"date":651,"type":52},"2024-01-26",{"date":653,"type":52},"2023-01-01",{"date":655,"type":22},"2027-07-01",{"name":657,"class":151},"Vastra Gotaland Region",{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":664,"eligibilityCriteria":665,"healthyVolunteers":12,"sex":131,"minAge":19,"maxAge":4,"enrollmentInfo":666,"targetDuration":4,"studyType":303,"phases":4,"briefSummary":667,"conditions":668,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":676,"locationsCount":200},"100528488","optical-guided-sentinel-node-biopsy-for-staging-of-vulvar-cancer-100528488","NCT06161428","Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer","Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer ( SENTIVUC II)","SENTIVUC II","Inclusion Criteria:\n\n* Patients with vulva cancer, tumor \\> 4 cm, multifocal tumor, or local recurrences in vulva\n\nExclusion Criteria:\n\n* Previous external irradiation of the vulva or groins\n* Former sentinel node or inguinal lymphadenectomy in the relevant groin\n* Known allergy to ICG or iodine\n* Patient is in active treatment for other cancer and\u002For disseminated disease",{"count":274,"type":22},"The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET\u002FCT imaging in women with vulva cancer tumour size \\>4 cm, multifocal tumors and local recurrences.",[669,31],"Vulva Cancer","2023-12-07",{"date":672,"type":52},"2023-12-13",{"date":674,"type":52},"2023-05-01",{"date":655,"type":22},{"name":677,"class":59},"Rigshospitalet, Denmark"]