View clinical trials related to Sentinel Lymph Node Biopsy.
Filter by:This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).
The aim of this randomized controlled trial (RCT) is to assess the Quality of Recovery (QoR) in Breast-conserving Surgery (BCS) with Sentinel Lymph Node Biopsy (SLNB) using Pectoral Nerves (PECS) Block and General Anesthesia (GA). The primary objectives are as follows: First, to determine if the PECS group exhibits better QoR; Second, to investigate if the PECS group experiences less postoperative pain and complications; Third, to examine if the PECS group demonstrates more stable hemodynamics.
The aim of the study was to evaluate the diagnostic value of MRI and/or SLN mapping alone or in combination in cervical (CC) and endometrial cancer (EC) patients.
Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.
The primary aim of this prospective, multicentre study is to determine whether the involved node can be marked using black carbon dye and successfully identified at the time of surgery. The secondary aims are to determine the concordance between the tattooed node and sentinel node, migration of black dye into other nodes, and false-negative rate of tattooed node (in patients undergoing ALND after NACT).
This study is for women with breast cancer and for adults with melanoma. Breast cancer is a type of cancer when cells in the breast turn into cancer cells, which may grow out of control. Melanoma is a type of skin cancer that starts in cells called melanocytes. These cells make a substance called melanin which gives the skin its color. In this study, people will have surgery to remove the lymph node closest to the site of their cancer. This lymph node is called the sentinel node. This is done to check if the cancer has spread from the original site to the sentinel node. This procedure is called a sentinel node biopsy. This study will provide more information on a potential new dye, called ASP5354, used in sentinel node biopsies. ASP5354 may help to show the lymph nodes more clearly during surgery. This will help the surgeon find the lymph node closest to the site of the cancer (sentinel node). The main aim of the study is to find the best dose of ASP5354 that clearly shows the lymph nodes during surgery. This is an open-label study. That means each person in the study and the study doctors knew that person received ASP5354. Each person will only receive 1 dose of ASP5354. This dose will consist of 2 to 4 injections of ASP5354 around the cancer site. Small groups of people will each receive a different dose of ASP5354. The first group will receive a low dose of ASP5354. If the lymph nodes are clearly seen, the next group will receive a lower dose of ASP5354 and the following group will receive a dose of ASP5354 that is higher than the dose the first group received. Then, the results will be checked by an independent panel of experts. Depending on the results, the next groups may start on the current doses of ASP5354 or may receive a higher dose. In this study, up to 6 doses of ASP5354 may be given, but each person only receives 1 of these doses. People that want to take part in the study will be checked by a study doctor. This will be on a separate visit before their surgery. Before surgery, people who take part in the study will be asked if they have any other medical problems. They will have a physical exam, an ECG to check their heart rhythm, and have their vital signs checked (blood pressure, pulse rate, and breathing rate). Other checks will include some blood and urine samples taken for laboratory tests. During surgery, a study surgeon will inject ASP5354 near the cancer site. They will record how clearly they can see the lymph nodes. Some blood samples will be taken for laboratory tests and an ECG will be done. After their surgery, people will be asked if they have any other medical problems. People will return to the hospital 9 days later for a check-up. The check-up will include a physical exam, an ECG to check their heart rhythm, and a check of their vital signs (blood pressure, pulse rate, and breathing rate). Other checks will include some blood samples taken for laboratory tests. People will be asked if they have any medical problems and asked to complete a feedback survey.
Neoadjuvant or primary systemic treatment is increasingly applied in the treatment of operable breast cancer. Down staging of the primary tumor is one of the important goals of neoadjuvant chemotherapy treatment (NCT), thereby permitting breast-conserving treatment without affecting the risk for a local relapse. Complete pathological response (pCR) rates after NCT vary across histological subtypes and can be more than 60% in HER2-positive disease with dual blockade therapy. Down staging of the axilla is also observed in patients initially presenting with metastatic lymph nodes. pCR rates in the axilla vary between 22% and 42% in reported series, again depending on tumor subtype. Omission of axillary lymph node dissection (ALND) can avoid the post-operative morbidity such as lymphedema in the short or long term follow-up. Metastatic lymph node status is hard to be stated as a pCR in the axilla by using physical examination or imaging such as ultrasonography or tomography after complete NCT. Good response to the axilla lymph node causing the difficulty of tissue proof by using core needle biopsy, though the investigator knew that biopsy stands for the definite tool for the confirmation of the residual disease. One proposed method to decrease the false-negative rate (FNR) is clip placement in the positive node at initial diagnosis with confirmation of clipped node resection at surgery. The correlation between the axillary lymph node identified on initial axillary ultrasound and the sentinel lymph nodes (SLNs) identified at surgery has not been fully evaluated. The concordance between percutaneous biopsy and the lymph node resected at the time of SLNB is not 100%. Sometimes, the initial node identified by ultrasound is not one of the SLNs. The impairment of the performance of SLNB might correlated to the alteration of lymphatic flow induced by tissue fibrosis or tumor deposits after NCT. The investigator hypothesized that the clip placement at diagnosis of node-positive disease with removal of the clipped node during SLNB reduces the FNR of SLNB after NCT. Here, we evaluate how often the lymph node containing the clip placed at percutaneous biopsy before chemotherapy was found at surgery to be one of the SLNs, and how often it was found in the nodes retrieved at ALND. In addition, the investigator report the impact of identification of the clipped node within the SLNs on the FNR of SLNB.
False negative rate (FNR) in patients who has accepted neoadjuvant therapy is high. Blue dye and radioisotope as dual-tracer can decrease FNR. Several large clinical trials showed that using dual trace with blue dye and radioisotope can reduce the FNR to less than 10%. But radioisotope is still not approved in China and can cause radiocontamination. A novel dual-tracer which can decrease the FNR in patients after neoadjuvant therapy is urged to be explored. Contrast enhanced ultrasonography (CEUS) can make the lymphatic drainage path and sentinel lymph nodes visible. Retrospective studies found that CEUS can locate SLN precisely. So this clinical trial aim to evaluate FNR, detective rate and numbers of SLN by using CEUS combined with blue dye as dual-tracer in sentinel lymph node biopsy in breast cancer patients after neoadjuvant therapy and the accuracy of CEUS for the diagnosis of lymph node metastasis before and after neoadjuvant therapy.
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.
Sentinel Lymph Node Biopsy (SLNB) after nipple sparing mastectomy (NSM) is controversial. This study aims to investigate feasibility of SLNB with radioisotope method.