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Sentinel Lymph Node clinical trials

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NCT ID: NCT06259513 Recruiting - Breast Cancer Clinical Trials

Omission of Axillary Surgery in Breast Cancer Patients

Start date: February 6, 2024
Phase: N/A
Study type: Interventional

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. We 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, Total 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. In 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- >/=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. The 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.

NCT ID: NCT06169787 Active, not recruiting - Sentinel Lymph Node Clinical Trials

Sentinel Lymph Nodes Biopsy in Cervical Cancer

Start date: October 14, 2023
Phase:
Study type: Observational

This study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage cervical cancer who underwent radical hysterectomy.

NCT ID: NCT06169072 Recruiting - Breast Cancer Clinical Trials

Sentinel Lymph Node Localisation With an Ultra-low Dose of Magtrace in Breast Cancer Patients

MagSnow2
Start date: January 1, 2023
Phase: Phase 2
Study type: Interventional

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 +/- blue dye, and to evaluate MRI breast artefacts and skin staining over time.

NCT ID: NCT06163963 Recruiting - Endometrial Cancer Clinical Trials

Sentinel Lymph Node in Early-Stage Endometrium Cancer

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

The aim of this prospective study is to investigate whether the detection rate of sentinel lymph node (SLN) with double tracer injected at two different sites may be increased compared to the standard use of a single tracer with single site (cervix) injection in early-stage endometrial cancer.

NCT ID: NCT06161428 Recruiting - Sentinel Lymph Node Clinical Trials

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

SENTIVUC II
Start date: May 1, 2023
Phase:
Study type: Observational

The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with vulva cancer tumour size >4 cm, multifocal tumors and local recurrences.

NCT ID: NCT06149377 Completed - Breast Cancer Clinical Trials

Impact of a Predictive Model on Sentinel Lymph Node Biopsy in Initially Lymph Node-positive, HER2-positive Breast Cancer

Start date: April 1, 2012
Phase:
Study type: Observational

The aim of the study was to develop and validate a nomogram to assess axillary pathological complete response (pCR) in patients with initially lymph node-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer and test its performance in guiding patient selection for sentinel lymph node biopsy (SLNB) following neoadjuvant systemic therapy (NST).

NCT ID: NCT06130241 Not yet recruiting - Sentinel Lymph Node Clinical Trials

Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Initially Node Positive Breast Cancer Patients, Could it Omit Axillary Dissection ?

Start date: November 30, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to determine the accuracy and safety of SLNB after neoadjuvant chemotherapy.

NCT ID: NCT06029504 Recruiting - Vulvar Cancer Clinical Trials

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)

SENTIVUC
Start date: January 1, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to investigate whether Sentinel Node biopsy can be performed without the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer, unifocal tumor < 4 cm (clinical stage IB and II). Further, to investigate the accuracy of combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor < 4 cm.

NCT ID: NCT05985551 Active, not recruiting - Breast Cancer Clinical Trials

Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment

MagNeo
Start date: January 1, 2020
Phase:
Study type: Observational

The goal of this study was to assess the feasibility of SLND by superparamagnetic iron oxide nanoparticles (SPIO) in patients with early breast cancer planned for primary systemic therapy (PST) and whether this is affected by the timeframe of SPIO administration. For this, patients with cN0/1 disease planned for PST received radioisotope as per routine on the day of surgery or the day before, and SPIO was injected in an extended timeframe, at any point from the day of surgery to before the induction of PST. The main points to investigate are: 1. If the SPIO detection rate and concordance to the radiosotope are affected by time of SPIO injection 2. If the nodal yield and the accuracy of the procedure are affected

NCT ID: NCT05935150 Recruiting - Breast Cancer Clinical Trials

Omission of SLNB in cN0 Early Breast Cancer

Start date: June 21, 2023
Phase: N/A
Study type: Interventional

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.