[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sentinel-lymph-node-biopsy-slnb\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sentinel-lymph-node-biopsy-slnb":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,60,86,115,148,176,203,226,249,273,309],{"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":17,"minAge":18,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100614371","upfront-targeted-axillary-dissection-for-luminal-breast-cancer-with-limited-axillary-involvement-100614371","NCT07278726","Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement","Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement: the UTAD Study of the Italian National Association of Breast Surgeons (ANISC)","UTAD","Inclusion Criteria:\n\n* Diagnosis of T0-T1-T2 ER+\u002FPR+ HER2- breast cancer with limited nodal involvement (1 or 2 suspicious lymph node on US, with at least 1 nodal positive cytology\u002Fhistology)\n* M0\n* Conservative surgery or mastectomy\n* Neoadjuvant treatment not recommended after a multidisciplinary discussion\n* Patients between 18 and 90 years old\n* Patients willing and able to follow the study procedures and available for follow-up over the entire duration of the study\n\nExclusion Criteria:\n\n* Psychiatric, addictive or any disorder, which compromises ability to give informed consent for participation in the study\n* Personal history of invasive breast cancer\n* Other invasive malignancies diagnosed in the last five years\n* Any condition that may expose the individual to a higher risk or preclude the study from achieving full compliance or completion\n* Contraindications to radiation therapy","90 Years",{"count":70,"type":21},150,"OBSERVATIONAL","The present study aims to avoid axillary lymph node dissection (ALND) in patients with an Ultrasound (US) detected positive preoperative lymph node involvement (1 or 2 suspicious lymph-nodes) and a needle histology\u002Fcytology placing a marker in the most suspicious node undergoing upfront surgery if neoadjuvant treatment is not indicated. The marked lymph node will be retrieved along with sentinel lymphnode(SLN)(s) to minimize the false-negative rate and only in case of ≥3 positive SLNs ALND will be performed, in order to minimize surgical overtreatment among women with preoperatively confirmed axillary nodal metastasis.",[74,28,75],"ALND","Targeted Axillary Dissection (TAD)","2026-06-15",{"date":78,"type":51},"2026-06-16",{"date":80,"type":51},"2026-01-28",{"date":82,"type":21},"2033-11",{"name":84,"class":58},"European Institute of Oncology",14,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100641655","evaluating-a-decision-aid-for-sentinel-lymph-node-biopsy-in-intermediate-risk-melanoma-100641655","NCT07653087","Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma","Mel73","Inclusion Criteria:\n\n1. Adults (≥18 years old) with a histologically confirmed diagnosis of cutaneous melanoma.\n2. Clinical stage I or II disease, for whom sentinel lymph node biopsy (SLNB) is being considered.\n3. Patients with either:\n\n   * An estimated risk of sentinel lymph node metastasis between 5 and 10 percent based on the MIA risk calculator, or\n   * A discordant risk scenario will be defined as a case in which the individualized probability of sentinel lymph node metastasis predicted by the MIA model falls into a different risk category (\\\u003C5%, 5-10%, or \\>10%) than the category suggested by clinicopathologic staging features used in NCCN guideline-based counseling.\n4. Willingness and ability to comply with study procedures.\n5. Ability to provide informed consent.\n6. Pregnant women, and other vulnerable populations are not specifically excluded unless they meet other exclusion criteria; the study presents minimal risk.\n\nExclusion Criteria:\n\n1. Patients with clinical evidence of nodal or distant metastatic disease at the time of consultation.\n2. Patients with prior sentinel lymph node biopsy or nodal surgery for the current melanoma diagnosis.\n3. Inability to speak or read English.\n4. Inability or unwillingness to provide informed consent.\n5. Prisoners",{"count":94,"type":21},66,[24],"This research study is testing a decision aid to help patients think through whether to have sentinel lymph node biopsy for melanoma.\n\nSentinel lymph node biopsy (SLNB) can be a difficult decision for some patients because the potential benefits and risks may not be clear. This study is being done to learn whether providing structured, easy-to-understand information helps patients feel more informed and less uncertain about their decision.\n\nPatients in this study will be given a paper decision aid (DA). Patients will be given other short questionnaires to complete before and after the decision aid.",[28,98],"Melanoma (Skin Cancer)",[100,101,102,103],"SLNB","Melanoma","Sentinel Lymph Node Biopsy","Decision Aid","NOT_YET_RECRUITING","2026-06-11",{"date":107,"type":51},"2026-06-17",{"date":109,"type":21},"2026-06",{"date":111,"type":21},"2028-01",{"name":113,"class":58},"University of Virginia",1,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":125,"studyType":71,"phases":4,"briefSummary":126,"conditions":127,"keywords":133,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100599511","audit-of-targeted-sentinel-node-biopsy-tsnb-in-patients-with-limited-nodal-disease-undergoing-primary-surgery-100599511","NCT07085442","Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery","NodeSMART - Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery","NodeSMART","Inclusion Criteria:\n\n* cT1-2N1M0 breast cancer\\*\n* FNA or core biopsy confirmed axillary nodal metastases\n* ≤2 abnormal nodes on imaging\n* Undergo a dual tracer or single tracer sentinel node biopsy along with removal of the marked node (Targeted Sentinel Node Biopsy, TSNB)\n* 1 or 2 macrometastases identified in the removed nodes, with at least three nodes removed\n* If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if 1 or 2 macrometastases are identified in the removed nodes, with at least three nodes removed.\n* If the node is not marked or the marked node is not removed, the patient will be eligible if 1 or 2 macrometastases are identified in the removed nodes, with at least three nodes removed.\n\n  * patients with T3 tumours on post-operative histology will remain eligible.\n\nExclusion Criteria:\n\n* Neoadjuvant chemotherapy\n* Previous ipsilateral axillary lymph node dissection\n* cT3-4 breast cancer\n* ≥3 abnormal nodes on imaging",{"count":124,"type":21},300,"5 Years","Axillary ultrasound scan (AUS) is routinely employed in the UK for preoperative axillary staging and can diagnose approximately 50 - 80% of node positive patients when combined with percutaneous needle biopsy techniques (either core-biopsy or fine-needle aspiration cytology). It is recognised that nodal burden is generally higher in clinically node negative patients with abnormal nodes on AUS and confirmed on needle-biopsy to be histologically positive than patients diagnosed as node positive on sentinel node biopsy (SNB). However, up to 40% of biopsy-proven node positive patients are found to have fewer than 3 involved nodes on subsequent axillary lymph node dissection (ALND) and are potential candidates for less extensive axillary surgery with axillary radiotherapy (ART) rather than ALND. The total number of abnormal nodes on ultrasound is a key predictor of overall nodal tumour burden.\n\nThe AMAROS and OTOASOR trials randomised patients with up to 2 positive sentinel nodes to either ALND or ART. These trials were conducted around the turn of the millennium and before routine use of AUS and therefore would have included a significant number of patients who were radiologically node positive (cN1). Likewise, the ACOSOG Z0011 trial that randomised a similar group of patients to either ALND or observation only, did not incorporate routine AUS and would have included some (radiological) cN1 patients. These trials revealed no adverse impact on disease-free or overall survival from omission of completion ALND.\n\nTargeted axillary dissection (TAD) was introduced a few years ago to reduce the false negative rate of SNB following neoadjuvant chemotherapy (NACT) and has been standardised as part of the ongoing ATNEC trial \\[ClinicalTrials.govNCT04109079\\]. This technique for axillary staging after NACT is increasingly being adopted in the UK and elsewhere. TAD is technically more straightforward and less challenging in patients undergoing primary surgery with no concerns about clip migration consequent to nodal shrinkage as part of treatment response to NACT. Furthermore, the risk of under-treating the axilla is offset by the protocol: if no disease is identified in the targeted nodes (false-negative case), then patients proceed to ALND, thereby ensuring adequate treatment. Unlike TAD following NACT, the presence of viable tumour within the sampled nodes is mandatory and finding fibrosis is irrelevant except as a response to nodal biopsy per se.\n\nCurrent ASCO guidelines support both SNB and TAD as staging options for patients with ultrasound-detected, biopsy-confirmed nodal disease. The Edinburgh randomised trials comparing four-node sampling with ALND demonstrated significantly lower arm morbidity with node sampling, supporting TAD as a less morbid appropriate alternative in this patient population.\n\nThe UK-ANZ POSNOC trial randomised 1,900 patients with \\\u003C3 macrometastases to either no further axillary treatment or additional axillary treatment. The study included cN1 patients with biopsy-confirmed nodal metastases who underwent sentinel node biopsy or TAD. Patients with \\\u003C3 macrometastases on final histology were randomised to receive no further axillary treatment or proceed with additional axillary treatment (ALND or ART). POSNOC trial will answer whether further axillary treatment provides any benefit in patients with low volume nodal disease on SNB or TAD.\n\nNotably, patients with biopsy-confirmed metastases and \\\u003C3 macrometastases on SNB\u002FTAD are biologically and clinically similar to patients with normal AUS who are later found to have low-volume disease on SNB. Clinical decision-making and patient outcomes are driven by tumour biology and overall disease burden rather than the method of nodal disease detection. Furthermore, AUS sensitivity is operator dependent and whether FNA or core biopsy was used to sample the node. A patient considered node negative on AUS by one radiologist may be diagnosed with core biopsy confirmed nodal metastases with another radiologist. Pending the results of POSNOC trial, patients with less than 3 macrometastases are generally advised further axillary treatment, and ART is preferred over ALND to reduce the risk of lymphoedema.\n\nNodeSMART is a prospective audit collecting data on patients undergoing TAD in the primary surgery setting. Its goal is to audit surgical outcomes and benchmark them against - a) Comparing technical outcomes with those from sentinel node biopsy in the primary surgery setting and TAD performed after neoadjuvant chemotherapy. b) Assessing rates of arm lymphoedema and disease progression relative to findings from the AMAROS and Z11 trials, and the POSNOC trial once results are available. The term \"Targeted Axillary Dissection\" is somewhat misleading in this context, as the marked (biopsied) node is removed alongside sentinel nodes - not in isolation. NodeSMART therefore refers to the procedure more accurately as Targeted Sentinel Node Biopsy (TSNB).",[27,128,129,28,130,131,132],"Axillary Lymph Nodes Dissection","Axillary Metastases","Node Positive Breast Cancer","Axilla; Breast","Axillary Ultrasound",[134,135,121,27,136,128,137],"Targeted Axillary Dissection","Targeted Sentinel Node Biopsy","Sentinel Node Biopsy","Axillary Node Clearance","2026-05-24",{"date":140,"type":51},"2026-05-28",{"date":142,"type":51},"2025-01-17",{"date":144,"type":21},"2032-12",{"name":146,"class":58},"University Hospitals of Derby and Burton NHS Foundation Trust",12,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":155,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":158,"studyType":71,"phases":4,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":114},"100632024","patent-blue-sln-in-early-ovarian-cancer-prospective-study-figo-i-ii-evaluating-patent-blue-sln-mapping-injection-into-ipuo-ligaments-in-situ-goals-assess-feasibility-and-accuracy-vs-standard-lymphadenectomy-to-minimize-surgical-morbidity-100632024","NCT07508306","Patent Blue SLN in Early Ovarian Cancer Prospective Study (FIGO I-II) Evaluating Patent Blue SLN Mapping. Injection Into IP\u002FUO Ligaments in Situ. Goals: Assess Feasibility and Accuracy vs Standard Lymphadenectomy to Minimize Surgical Morbidity","Evaluation of Sentinel Lymph Node Biopsy Using Patent Blue Dye in Early-Stage Ovarian Cancer: A Prospective Observational Study","Inclusion Criteria:\n\n* Age : aged 18 years-old or older\n* Diagnosis: Suspected Ovarian cancer on MRI finding (O-RADs 4 or 5)\n* FIGO stage: Stage I or II ( Based on MRI and scanner finding)\n* Planned Procedure: Patients with planned for surgical complete stadification including pelvic and para-aortic lymphadenectomy\n* Consent: Signing of the written informed consent after full information has been provided\n\nExclusion Criteria:\n\n* Suspicious nodal involvement: Presence of suspicious lymph nodes on preoperative imaging (generally defined by a short-axis diameter ≥ 10 mm).\n* Disease extension: Radiological or intraoperative evidence of extra-pelvic metastases or peritoneal carcinomatosis.\n* Surgical history: History of lymphadenectomy, lymph node sampling, or major vascular surgery involving the aorta or the iliac vessels.\n* History of radiotherapy: Patients who have previously undergone pelvic or abdominal radiotherapy.\n* Allergies: Known allergy or adverse reaction to patent blue dyes.","FEMALE",{"count":157,"type":21},30,"6 Months","the standard of care in case of early ovarian cancer (stage I or II) is a complete surgery. This surgery includes : hysterectomy (remove of the uterus), bilateral salpingo-oophorectomy (remove of the adnexa), omentectomy (remove of the epiploon), bilateral pelvic lymphadenectomy (remove of pelvic lymph nodes) and para-aortic lymphadenectomy (remove of para-aortic lymph nodes). This procedure is diagnostic, curative and prognostic surgery. In fact, it allows us provider care giver to stratify the stage of the cancer, hence we give the appropriate adjuvant therapy.\n\nHowever, this surgery, especially the extended lymphadenectomy, is associated with some risks: lymphocele, vessel injury, blood loss, morbidity, long recovery period ... In order to reduce these risks, we propose a sentinel lymph node biopsy. This intervention allows us to detect first lymph node relay whether pelvic or para-aortic.\n\nIn our study, we chose the patent blue dye as a tracer. This tracer is widely used in oncologic surgery (for example in breast cancer) and approved but not in ovarian cancer yet.\n\nDuring surgery for early stage ovarian cancer, we will inject the patent blue dye on both side of the ovarian tumor. Then, we will check for first colorful lymph node, in both pelvic and para-aortic regions. We will send these dissected lymph node to pathology for analysis. Finally, we will continue the procedure as the standard of care.\n\nOur objective is to compare the results between the sentinel lymph node and the complete lymphadenectomy and to study the technique of sentinel lymph node biopsy using the blue patent dye as tracer.",[28,161],"Early Stage Ovarian Tumors",[163,164,165,166],"early stage ovarian cancer","sentinel lymph node","sentinel lymph node biopsy","Patent blue dye","2026-03-31",{"date":169,"type":51},"2026-04-02",{"date":171,"type":21},"2026-04-15",{"date":173,"type":21},"2028-02-28",{"name":175,"class":58},"Faculty of Medicine of Tunis",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":155,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":192,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":199,"leadSponsor":201,"locationsCount":4},"100585301","sentinel-node-mapping-versus-comprehensive-lymphadenectomy-in-p53-mutated-endometrial-cancer-a-non-inferiority-randomized-trial-100585301","NCT06900582","SENTInel Node Mapping Versus Comprehensive Lymphadenectomy in p53-Mutated Endometrial Cancer: A Non-Inferiority Randomized Trial","Comparing SENTInel Node Mapping to Comprehensive Lymphadenectomy in p53-Mutated EndoMETRial Cancer: a Prospective, Open-label, Controlled, Randomized, Non-inferiority, De-escalation Trial","SENTIMETREP53","Inclusion Criteria:\n\n1 . ≥ 18 years old 2. High-risk endometrial cancer, as defined by the ESGO-ESTRO 20211 histological and molecular classification, with p53 mutation confirmed on endometrial biopsy or curettage in the two months before the surgery 3. Magnetic Resonance Imaging (MRI) confirmed FIGO 2023 stage I and II endometrial cancer, i.e., confined to the uterine corpus, ovary and the cervical stroma.\n\n4\\. Participant with a scheduled surgical intervention (total hysterectomy and bilateral salpingo-oophorectomy, with omentectomy in the case of serous, carcinosarcoma and undifferenciated type EC) 5. Eligible for comprehensive lymphadenectomy by laparoscopy 6. Participant with a negative Positron Emission Tomography scan (PET-CT scan) for lymph node involvement in the two months before the intervention 7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1 8. Participant able to provide written informed consent\n\nExclusion Criteria:\n\n1. Recurrent EC\n2. Previous chemo-, radio, or endocrine therapy for EC\n3. Any contra-indication to lymphadenectomy and\u002For chemotherapy\n4. Any contraindication to laparoscopy\n5. Any criteria, based on the investigator's judgment, that would contraindicate the surgical procedure (e.g., but not limited to, anesthetic risk, bleeding, significant comorbidities)\n6. Any known disorder or circumstances making participation in trial and follow-up questionable\n7. Patients with other malignancies for whom the disease(s) and\u002For associated treatment(s) might have an impact on the patient's cancer prognosis\n8. Known HIV-infection or AIDS\n9. Simultaneous participation in another interventional clinical trial\n10. Within the exclusion period following participation in another interventional clinical trial\n11. Patients with difficulties in reading or understanding French, or an inability to understand the delivered information\n12. Patients in emergency medical situations\n13. Patient under guardianship or limited guardianship",{"count":185,"type":21},374,[24],"This study evaluates surgical strategies for treating patients with FIGO 2023 stage I and II high-risk endometrial cancer (EC) exhibiting p53 mutations. The trial aims to assess whether a less invasive sentinel lymph node (SLN) mapping approach provides non-inferior oncological outcomes compared to the current standard of systematic pelvic and para-aortic lymphadenectomy (PL+PALND). By minimizing surgical morbidity, this study seeks to determine if SLN mapping can safely replace comprehensive lymphadenectomy without compromising disease-free survival (DFS). Eligible patients will be randomized to undergo either sentinel lymph node mapping or complete lymphadenectomy, followed by standard hysterectomy and bilateral salpingo-oophorectomy. The primary outcome is DFS at 36 months, with secondary outcomes including overall survival, disease-specific survival, perioperative complications, and quality of life.",[189,190,191,28],"Lymphadenectomy","Endometrial Cancer","Gene, p53",[193,38,189,194],"Endometrial cancer","p53 mutation","2026-02-13",{"date":197,"type":51},"2026-02-17",{"date":109,"type":21},{"date":200,"type":21},"2031-10",{"name":202,"class":58},"University Hospital, Strasbourg, France",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":155,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":224,"locationsCount":225},"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":212,"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.",[27,28,29,30,31,32,33,34,35,216],"Mastectomy",[37,38,40,216,42,44,43,41,46],"2026-01-15",{"date":220,"type":51},"2026-01-23",{"date":222,"type":51},"2022-08-22",{"date":109,"type":21},{"name":57,"class":58},2,{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":155,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":114},"100599165","sentinel-lymph-node-biopsy-after-neoadjuvant-chemotherapy-in-ibc-100599165","NCT07080944","Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC","Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial","SYMPHONY","Inclusion Criteria:\n\n* Female patients over 18 years of age with clinically and biopsy-proven stage IIIB cT4d cN0-2 M0 breast cancer as assessed by clinical exam and imaging\n* Patients receiving NACT and having a nodal complete clinical response (ycN0) as assessed by physical exam and imaging (ultrasound and PET)\n* Ability to understand and willingness to sign informed consent document and comply with study procedures\n\nExclusion Criteria:\n\n* Patients with cN3 stage at diagnosis\n* Participants with stage IV (metastatic) breast cancer\n* Participants with positive contralateral axillary nodes identified on standard imaging studies (mammograpy, MRI, ultrasound) and cito-histologically ascertained\n* Patients with a prior history of ipsilateral breast cancer\n* Pregnant patients\n* Patients after NACT with persistent palpable axillary nodes, as assessed by physical exam, or with persistent pathological axillary nodes, as assessed by imaging\n* Patients not consenting to ALND",{"count":235,"type":21},75,[24],"This study will prospectively determine the feasibility and oncological safety of sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) in inflammatory breast cancer patients traditionally considered ineligible for SLNB due to locally advanced cancer with skin\u002Fchest wall involvement (cT4d) and heavy nodal burden at presentation (cN1\u002FN2). This study will also assess the identification rate of sentinel lymph-node (SLN) (using single tracer mapping) after NACT in this patient population. Finally, the study will determine the long-term outcome of such cohort.",[239,28,240],"Invasive Breast Carcinoma","Neoadjuvant Chemotherapy","2026-01-02",{"date":243,"type":51},"2026-01-06",{"date":245,"type":51},"2025-12-12",{"date":247,"type":21},"2030-08",{"name":84,"class":58},{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":155,"minAge":18,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":259,"conditions":260,"keywords":263,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":114},"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","75 Years",{"count":258,"type":21},60,"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.",[261,30,28,262],"Breast Cancer Metastatic","Metastasis",[254,27,30,262],"2025-08-27",{"date":266,"type":51},"2025-09-04",{"date":268,"type":51},"2025-02-01",{"date":270,"type":21},"2026-12-01",{"name":272,"class":58},"Yunnan Cancer Hospital",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":291,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":308},"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":283,"type":21},508,[24],"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.",[287,288,289,290,102,28,30],"Mouth Neoplasms","Oral Cancers","Oral Squamous Cell Carcinoma (OSCC)","Oral Squamous Cell Carcinomas",[292,293,165,294,295,296,297],"mouth neoplasms","neck dissection","survival","morbidity","oral cancers","oral squamous cell carcinoma","2025-07-14",{"date":300,"type":51},"2025-07-17",{"date":302,"type":51},"2025-04-16",{"date":304,"type":21},"2034-04",{"name":306,"class":307},"Tata Memorial Hospital","OTHER_GOV",3,{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":315,"sex":155,"minAge":18,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":319,"conditions":320,"keywords":324,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":114},"100576089","phase-2-photo-medicine-guided-dual-approach-for-reoperation-of-sentinel-lymph-nodes-in-locally-recurrent-breast-cancer-patients-100576089","NCT06780748","Photo-medicine-Guided Dual Approach for Reoperation of Sentinel Lymph Nodes in Locally Recurrent Breast Cancer Patients","Inclusion Criteria:\n\n* Patients with ipsilateral locally recurrent breast cancer who previously underwent ipsilateral axillary surgery.\n* Female patients aged 18 years or older.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Patients who voluntarily decide to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with distant metastases.\n* Patients who previously underwent ipsilateral mastectomy.\n* Pregnant or breastfeeding women.\n* Patients with a general condition that impairs the ability to understand or provide informed consent.",true,{"count":157,"type":21},[318],"PHASE2","Sentinel lymph node biopsy (SLNB) is essential for staging and treatment planning in early breast cancer patients. As a less invasive procedure, it has replaced axillary lymph node dissection (ALND) by reducing complications and improving patient outcomes. However, the 10-year local recurrence rate for breast cancer is approximately 2-10%, and the role of SLNB in the surgical management of recurrent breast cancer remains unclear.\n\nAccording to the NCCN guidelines and Korean Breast Cancer Treatment Recommendations, surgical management for recurrent breast cancer includes mastectomy and axillary lymph node surgery for patients who have previously undergone breast-conserving surgery and radiotherapy. For axillary recurrence, surgery is recommended if feasible, followed by radiotherapy. Conversely, the ASCO guidelines recommend SLNB for surgically resectable recurrent breast cancer, and recent studies have reported promising outcomes for repeat sentinel lymph node biopsy (reSLNB). Vugts G et al. demonstrated an 80.1% tumor-negative rate with reSLNB, suggesting that ALND could be avoided in many cases.\n\nAlthough reSLNB offers the advantage of reducing unnecessary invasive procedures and associated complications, challenges remain due to disrupted lymphatic pathways in patients who have previously undergone surgery and radiotherapy. Additionally, research on the long-term prognosis of these patients is still limited.\n\nThis study aims to evaluate the detection rate of sentinel lymph nodes using a photo-medicine-based dual localization technique that combines traditional radiotracer methods with indocyanine green-fluorescence (ICG-F) in patients undergoing reSLNB for locally recurrent breast cancer.",[27,321,28,322,323],"Locally Recurrent Breast Cancer","Reoperation","ICG (indocyanine Green)",[37,325,28,322,326],"Locally Recurrent Breast cancer","ICG(indocyanine green)","2025-01-13",{"date":142,"type":51},{"date":330,"type":51},"2023-08-13",{"date":332,"type":21},"2025-12-31",{"name":334,"class":307},"National Cancer Center, Korea"]