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Sentinel Lymph Node clinical trials

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NCT ID: NCT04225858 Not yet recruiting - Breast Cancer Clinical Trials

Avoiding Sentinel Lymph Node Biopsy in Breast Cancer Patients After Neoadjuvant Chemotherapy

ASICS
Start date: January 2020
Phase: N/A
Study type: Interventional

This study evaluates whether SLNB can safely be omitted in breast cancer patients with HER2+ or TN tumors who achieve a radiological complete response on MRI after neoadjuvant systemic therapy

NCT ID: NCT04156841 Recruiting - Breast Cancer Clinical Trials

Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)

Start date: August 1, 2019
Phase:
Study type: Observational

Objective: To investigate the current clinical practice of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China. Methods: The data of early breast cancer patients who underwent SLNB in 40 Grade III Level A hospitals in China in 2018 will be collected. Different centers, tracer methods, molecular typing and neoadjuvant chemotherapy will be used as stratification factors to analyze the implementation rate, number of detections, positive rate of SLNB and the follow-up treatment.

NCT ID: NCT04147780 Completed - Sentinel Lymph Node Clinical Trials

Sentinel Node Extended in Squamous Cell Vulvar Cancer

SNEX
Start date: December 14, 2019
Phase:
Study type: Observational

The aim of this study is to investigate the feasibility of sentinel node biopsy in patients with squamous cell vulvar cancer, currently not regarded suitable for the sentinel node technique, i.e. patients with tumors ≥4cm, multifocal tumors or locally recurrent disease. A positive result of this pilot study might constitute the basis for a future full-scale multinational trial.

NCT ID: NCT04109079 Recruiting - Breast Cancer Clinical Trials

Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy

ATNEC
Start date: February 26, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04073706 Recruiting - Surgery Clinical Trials

Sentinel Node Biopsy in Endometrial Cancer

ENDO-3
Start date: January 18, 2021
Phase: Phase 3
Study type: Interventional

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. Primary Outcome Stage 1: Proportion 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. Primary Outcome Stage 2: Treatment 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/or histological results.

NCT ID: NCT03931044 Recruiting - Gastric Cancer Clinical Trials

Fluorescence Image-Guided Lymphadenectomy in Robotic Gastrectomy

IG-MIG
Start date: April 2019
Phase: N/A
Study type: Interventional

Gastric cancer is a worldwide challenge due to its spread, even epidemic in some areas, and the high mortality rates. Lymphadenectomy is considered the fundamental step during radical gastrectomy. In recent years, some researchers have tried to find a way to improve the surgical identification of the lymphatic drainage routes and lymph node stations. This new surgical frontier is the so called "navigation surgery". Among the different reported solutions, lately, the indocyanine green (ICG) has drawn attention. It is a fluorescence dye, that can be detected in the near infrared spectral band (NIR). The development of specific fluorescence imaging devices has allowed surgeons to visualize tumors, vascular and lymphatic structures. The Da Vinci Xi robotic system has an integrated imaging technology that has been used in colo-rectal and hepato-biliary surgery. However, up to date, the combined use of fluorescence imaging and robotic technology has not been evaluated during lymphadenectomy in gastric cancer. The general design of the present study is to evaluate the role of fluorescence imaging during robotic lymphadenectomy for gastric cancer.

NCT ID: NCT03917771 Completed - Sentinel Lymph Node Clinical Trials

Early Detection of Lower Extremity Lymphedema After Lymphadenectomy in Gynecological Cancer

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

This study aims to detect and treat early lower limb lymphedema secondary to lymphadenectomy with the aim of increasing the quality of life of patients with this chronic condition. To this end, a group of patients (treatment group) will be referred to the Rehabilitation service for a previous consultation and after surgery where lymphedema could be detected early. In addition, the usual follow-up will be carried out in Gynecology Oncology consultation (GO). In the second group, also called control, will be performed the usual follow-up in GO. For this we randomize to one of these two groups. The research project has the favorable report of the Center's Clinical Research Ethics Committee

NCT ID: NCT03900104 Completed - Endometrial Cancer Clinical Trials

Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

The investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method.

NCT ID: NCT03899441 Completed - Clinical trials for Perioperative/Postoperative Complications

Multimedia Aid Gynecologic Counseling and Consent

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This is an interventional trial to introduce two short animated videos into preoperative counseling/consent and to compare patient comprehension and satisfaction with a multimedia approach compared to standard of care currently. The investigators anticipate that patients will retain more information about their surgery and peri-operative care and will be more satisfied with a multimedia approach.

NCT ID: NCT03898687 Completed - Melanoma Clinical Trials

The Use of Magtrace®/Sentimag® in Sentinel Node Biopsy for Malignant Melanoma. The Magmen Study.

MAGMEN
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

To evaluate the use of superparamagnetic iron oxide (Magtrace®) as a tracer in sentinel node biopsy in malignant melanoma of the extremities, and to evaluate the possible role of Magtrace®-MRI for staging. Primary objective: • To evaluate if Magtrace®/Sentimag® can be used to identify SN in malignant melanoma with the same diagnostically reliability as the currently used method of Technetium 99m and Patent blue. Secondary objectives: • To evaluate if Magtrace®-MRI can predict sentinel node status in melanoma. This is a feasibility phase I, interventional single arm study. All patients included in the study will receive the same management. 20 patients will be included in the study. An enrollment time of 6-12 months is expected. Primary endpoint • To determine the detection rate of Magtrace®/Sentimag® in comparison to SNB using technetium and blue dye in patients with malignant melanoma of the extremities. Secondary endpoint • To evaluate Magtrace®-MRI sensitivity and specificity as a preoperative tool for staging in malignant melanoma.