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Sentinel Lymph Node clinical trials

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NCT ID: NCT05437380 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC

Start date: September 20, 2022
Phase: N/A
Study type: Interventional

Head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Cervical lymph node metastasis is frequently encounted on the date of diagnosis. Surgical resection is one of the most important treatment methods for head and neck squamous cell carcinoma with or without lymph node metastasis. At present, for cN0 patients, prophylactic neck dissection is recommended for squamous cell carcinoma originating in suprglottic, hypopharyngeal and oropharyngeal areas et al. Related studies reported that less than 30% of patients with cN0 were confirmed to have lymph node metastasis in postoperative pathological examination, who underwent neck dissection. Unnecessary neck dissection may increase complication incidence, such as neurovascular injury, chylous leakage, sialosyrinx. Accurate preoperative assessment is helpful to reduce unnecessary neck dissection. Sentinel lymph node biopsy were proved to be effective in reducing prophylactic lymph node dissection in breast cancer, melanoma and other malignant tumors. Compared with γ probe detection and indolyanine green injection, microbubble and contrast-enhanced ultrasound has no radiation and disturbance to resection margins in sentinel lymph nodes detection. Furthermore, surgeons could conduct lymph node puncture biopsy simultaneously under ultrasound guidance, which can further minimize surgical trauma. At present, the role of microbubble and contrast-enhanced ultrasound in sentinel lymph node detection and biopsy is rarely reported in head and neck squamous cell carcinoma. This study aims to explore the accuracy of peritumoral microbubbles and contrast-enhanced ultrasound for sentinel lymph nodes biopsy in predicting cervical lymph node metastasis in head and neck squamous cell carcinoma.

NCT ID: NCT05365204 Recruiting - Breast Cancer Clinical Trials

A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients

Start date: April 8, 2022
Phase: Phase 1
Study type: Interventional

A study for dosage-image optimization of 6% hydroxyethyl starch diluted indocyanine green for near-infrared fluorescence navigated sentinel lymph node mapping for breast cancer patient.

NCT ID: NCT05365191 Recruiting - Breast Cancer Clinical Trials

A Study Evaluating Near-infrared Zone II Imaging in Sentinel Lymph Node Mapping in Breast Cancer Patients

Start date: April 8, 2022
Phase: N/A
Study type: Interventional

This study aims for evaluating near infrared zone II imaging in sentinel lymph node mapping in breast cancer patients.

NCT ID: NCT05359783 Active, not recruiting - Breast Cancer Clinical Trials

Sentinel Node Localization and Staging With Low Dose Superparamagnetic Iron Oxide

MAGSNOW
Start date: November 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Sentinel lymph node (SLN) status is pivotal for treatment decisions in breast cancer patients. The dual technique with Technetium99m (Tc99) and blue dye (BD) is yet the current routine for SLN detection. However, the same reliability has been presented by superparamagnetic iron oxide nanoparticles (SPIO). The aim of this study was to determine if SLN detection using ultra-low dose SPIO is feasible.

NCT ID: NCT05288686 Active, not recruiting - Breast Cancer Clinical Trials

Use of Superparamagnetic Iron Oxide (SPIO) in Sentinel Lymph Node Detection for Breast Cancer

Start date: July 24, 2018
Phase: N/A
Study type: Interventional

Sentinel lymph node biopsy is mandatory during breast cancer operation for disease staging and treatment. The localization of sentinel lymph node is by the injection of radioisotope and blue dye, which is the gold standard. However the use of radioisotope and blue dye are associated with specific drawbacks. Superparamagnetic iron oxide is a magnetic tracer which is FDA-approved for sentinel lymph node localization. The hypothesis of this study is superparamagnetic iron oxide can replace the conventional dual mapping of radioisotope and blue dye in the detection of sentinel lymph nodes for early breast cancers.

NCT ID: NCT05191212 Recruiting - Sentinel Lymph Node Clinical Trials

The Role of Real-time Appearance of Lymphatic Flow in Lymphatic Mapping in Endometrial Cancer

Start date: July 13, 2021
Phase: N/A
Study type: Interventional

Purpose of the study Primary treatment of clinical early stage endometrial cancer is total hysterectomy, bilateral salpingo-oophorectomy, and lymph node dissection for staging. It was stated in the National Comprehensive Cancer Network (NCCN) guideline that sentinel lymph node biopsy can be performed as an alternative to systematic lymphadenectomy, including high-risk endometrial cancer histologies (2). In a study, the rate of bilateral sentinel lymph node detection in sentinel lymph node mapping using the cervical injection technique of indocyanine green was found to be 73.3%. After re-injection of cervical indocyanine green in patients whose sentinel lymph node could not be detected, the rate of detection of bilateral sentinel lymph nodes increased to 94.5% (4). However, repeated cervical injection causes a waste of time. In our clinic, sentinel lymph node mapping method is applied using indocyanine green for lymph node dissection for staging purposes, since the robotic system has a fluorescent imaging system in patients operated with robotic surgery for endometrial cancer. In accordance with the literature, our bilateral sentinel lymph node detection rate was 75%. During cervical indocyanine green injection in our last 6 patients, the lymphatic channels in the pelvic region were followed simultaneously with the injection and indocyanine injection was performed until the channels were seen transperitoneally. Bilateral lymphatic channels were seen in all of these patients, and sentinel lymph nodes were found bilaterally in all of them. The aim of the planned study is to compare the traditional cervical indocyanine green injection and indocyanine injection until the lymphatic channels are visualized for bilateral detection of sentinel lymph nodes in patients with clinical early stage endometrial cancer. Material-Method The number of patients planned to be included in the study was calculated as 24 patients in both groups, with an alpha error value of 5% and a statistical power above 80% when the bilateral sentinel lymph node detection rate was 75% in the traditional method and 99% in the study group (SPH analytics 2021).

NCT ID: NCT05184140 Recruiting - Ovarian Cancer Clinical Trials

Mapping Sentinel Lymph Node in Initial Stages of Ovarian Cancer

MELISA
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Epithelial ovarian cancer (EOC) diagnosed in the initial stage (stage I-II) require complete staging surgery to histologically assess the possible existence of peritoneal or lymph node disease. Systematic pelvic and paraaortic lymphadenectomy in stage I-II EOC is essential since confirming the presence of lymph node metastases means re-staging the disease as stage III. This change of stage has important prognostic and therapeutic implications. However, the lymph node involvement rate is around 10-30% (average of 15%). Systematic pelvic and para-aortic lymphadenectomy carries a risk of intraoperative complications, as well as longer operative time, postoperative complications and longer hospital stay. Moreover, by now there is no evidence suggesting a possible therapeutic value. The sentinel lymph node (SLN) detects the first level of lymph node drainage. The absence of metastases in the SLN predicts the absence of tumor infiltration of the rest of lymph nodes of the same anatomical region and allows to safely avoid lymphadenectomy and its associated morbidity. In addition, the exhaustive evaluation of the SLN by ultrastaging and immunohistochemical study allows to increase the detection of microscopic disease. Sentinel lymph node (SLN) biopsy, implemented in clinical practice in other gynecological tumors (breast, vulva, cervix or endometrium), has been studied very little in the initial ovarian epithelial cancer. Unlike other gynecological tumors, there are multiple anatomical and technical aspects that largely explain this lack of information. The double ovarian vascularization that accompanies lymphatic drainage explains this higher complexity. Therefore, at the present time, the detection of SLN in the initial EOC remains an experimental area without applicability in clinical practice. There are multiple doubts and issues to be resolved regarding the different tracers, the site and time injection and the actual accuracy of the SLN versus the lymphadenectomy.

NCT ID: NCT05076942 Recruiting - Vulvar Cancer Clinical Trials

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

GROINSS-VIII
Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

Vulvar cancer patients with SN-metastasis > 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.

NCT ID: NCT04972682 Completed - Endometrial Cancer Clinical Trials

[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer

SENTRY
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.

NCT ID: NCT04930692 Not yet recruiting - Breast Neoplasms Clinical Trials

A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The main hypothesis of this study is that contrast-enhanced CT lymphography can be used for preoperative visualization of sentinel lymph nodes in breast cancer patients. We assume that CT lymphography is a high-sensitivity and high-specificity method for sentinel lymph nodes' mapping in breast cancer patients. We also assume that positive predictive value and negative predictive value for identification of presence or absence of metastases in sentinel lymph nodes (SLN) will be high enough for preoperative diagnosis of SLN metastases in breast cancer patients. This study will use CT lymphography with periareolar injection of iopamidol and standard protocols of sentinel lymph nodes biopsy using intraoperative indocyanine green (ICG) fluorescence.