Sentinel Lymph Node Biopsy

7

Review clinical trials related to Sentinel Lymph Node Biopsy. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

NAUTILUS-04: No Axillary Surgical Treatment in Low-Risk Clinically Node-Negative Breast Cancer Without Whole-Breast Radiotherapy

The safety of omitting sentinel lymph node biopsy (SLNB) has been established only in patients undergoing breast-conserving surgery with whole-breast radiotherapy, as demonstrated in the prior randomized trials. Whether SLNB can be omitted in patients who will not receive whole-breast radiotherapy remains unknown, despite the parallel expansion of radiotherapy de-escalation in low-risk populations. NAUTILUS-04 is a prospective, multicenter, randomized, phase III non-inferiority trial evaluating the oncologic safety of SLNB omission in postmenopausal patients with low-risk, clinically node-negative breast cancer who are not planned to receive whole-breast radiotherapy. Eligible patients are postmenopausal women aged 55 years or older with estrogen receptor-positive, HER2-negative invasive breast cancer, clinical T1-2 and clinically node-negative disease confirmed by physical examination and axillary ultrasound, without neoadjuvant systemic therapy. Patients must be planned for one of three local treatments: breast-conserving surgery without radiotherapy, breast-conserving surgery with accelerated partial breast irradiation, or mastectomy without radiotherapy. A total of 1,520 patients will be randomized 1:1 to SLNB or no axillary surgery, stratified by planned breast surgery (breast-conserving surgery versus mastectomy) and age (55-64 versus 65 years or older). The primary endpoint is 5-year invasive disease-free survival. Secondary endpoints include 5-year axillary recurrence-free survival, distant recurrence-free survival, overall survival, and quality of life assessed by the EORTC QLQ questionnaire.

Participants needed: 1,520
Trial details
Age: 55+Biological sex: FemaleType: InterventionalSponsor: Wonshik HanUpdated: Oct 8, 2026Locations: 1
Eligibility criteria

Postmenopausal women aged 55 years or older [+12]

Clinically or radiologically suspicious axillary lymph nodes [+6]

Status: Recruiting

No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy

NEO-NAUTILUS is a prospective, multicenter, randomized phase III clinical trial to evaluate whether omitting axillary lymph node surgery (ALND or SLNB) in clinically lymph node-negative breast cancer patients after neoadjuvant chemotherapy is non-inferior to performing SLNB in terms of 5-year disease-free survival.

Participants needed: 464
Trial details
Phase: Phase 3Age: 19+Biological sex: FemaleType: InterventionalSponsor: Seoul National University HospitalUpdated: Jan 28, 2026Locations: 1
Eligibility criteria

Women aged ≥19 years. [+8]

History of any cancer within the past 5 years. [+6]

Status: Recruiting

Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma

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/robotic 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.

Participants needed: 341
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Meander Medical CenterUpdated: Nov 20, 2025Locations: 1
Eligibility criteria

Oral and written informed consent (IC) [+5]

Patients who opt for active follow-up instead of surgery following shared decisi... [+12]

Status: Recruiting

Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative

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. The main questions it aims to answer are: * Survival outcomes * Morbidity outcomes * Cost-effectiveness Participants 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.

Participants needed: 508
Trial details
Age: 18-80Biological sex: AllType: InterventionalSponsor: Tata Memorial HospitalUpdated: Jul 17, 2025Locations: 3
Eligibility criteria

Age >18 years of age [+6]

Previous surgery in the head and neck region, [+4]

Status: Recruiting

Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer

The aim of this study is to compare two types of lymphadenectomy (transperitoneal vs. paracervical) during the lymphadenectomy phase of endometrial cancer staging surgery performed using V-NOTES, a new and advanced technique. This study seeks to optimize the V-NOTES technique for endometrial cancer staging. This randomized, prospective, controlled study will include patients diagnosed with endometrial cancer via histology, following physical examination and imaging, and who are electively scheduled for the V-NOTES endometrial cancer staging procedure. Patients will be randomized into two groups: the transvaginal paracervical lymphadenectomy group and the transperitoneal lymphadenectomy group. The parameters related with surgical and functional outcomes will be compared in both groups.

Participants needed: 52
Trial details
Age: 18-85Biological sex: FemaleType: InterventionalSponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUpdated: Mar 20, 2025Locations: 1
Eligibility criteria

Participants whose endometrial biopsy resulted in endometrial cancer and whose d... [+2]

Contraindications to using methylene blue dye or contraindications to the vNOTES... [+3]

Status: Recruiting

Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer

SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies.

Participants needed: 508
Trial details
Age: 18-70Biological sex: AllType: ObservationalSponsor: Henan Cancer HospitalUpdated: Dec 17, 2024Locations: 1
Eligibility criteria

Patients With ECOG Score 0-1 Points [+10]

Stage IV (metastatic) breast cancer; [+6]

Status: Recruiting

The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.

The role of small-volume lymph node disease (ITC and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (SLN) procedure is not clearly defined. This study was designed to create a dataset of patients with lymph nodal disease. Data on type and volume of lymph nodal disease, therapeutic choices and oncological outcomes (DFS, OS, recurrence rate) will be collected and analyzed. This will allow to define the groups of patients who may need or for whom it can be avoided any adjuvant treatment on the basis of lymph node status.

Participants needed: 500
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUpdated: Aug 17, 2022Locations: 1
Eligibility criteria

Early stage endometrial cancer scheduled for SLN procedure [+3]

Previous (<5 years) or concomitant malignancy other than non-melanoma skin cance... [+2]