Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Neoplasms, Germ Cell and Embryonal

Testicular Neoplasms

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Germ Cells Tumors

Testicular Germ Cell Tumor

a robot-assisted laparoscopic sentinel node procedure.

a robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis

sentinel node procedure

Joost Blok, MD

Simon Horenblas, MD, PhD

Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.

Current practice in patients with Clinical Stage I (CS I) testicular germ cell tumour is active surveillance after orchiectomy, with relapses occurring in 15-20% of patients. The majority of relapses occur in the lymph nodes as lymphogenic spread is the dominant route of dissemination. A sentinel node procedure, in which the sentinel lymph node is resected and pathologically examined, could be more reliable to identify patients who are likely to relapse.

Early identification of patients with micro-metastases in the sentinel node makes it possible to treat these patients at the earliest possible moment. Absence of metastases could lead in the future to a less intensive follow up protocol than the present one.

Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour

identify patients who have such a low risk of cancer recurrence that it is not necessary anymore to be included in current active surveillance protocols by removing the sentinal lymph node to check for occult metastasis

The Netherlands Cancer Institute

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Coelioscopy or laparotomy (based on the tumor size) after a colorimetric tracer injection

Detection of sentinel node

Emile DARAÏ, MD

The purpose of this study is to investigate the relevance of sentinel node in endometrial cancer. Sentinel node is thought to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy.

To investigate the relevance of sentinel node in endometrial cancer. Sentinel node is though to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy. The objective of our trial is to validate the concept of sentinel node in endometrial cancer.

Sentinel Node and Endometrial Cancer

Validation of the Sentinel Node in Endometrial Cancer

Assistance Publique - Hôpitaux de Paris

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Neoplasm Metastasis

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

Participants will indergo the standard treatment for their disease ( i.e. brachytherapy) but a sentinel node procedure will be added to their treatment

Injection of radio-active tracer in the tumor before brachytherapy treatment, visualization of sentinel nodes by SPECT, and extirpation of sentinel nodes by surgery

Sentinel node procedure

Michal Czwerwinski, MD

Lia Verhoef, MD, PhD

Abrahim Al-Mamgami, MD, PHD

Michal Czerwinski, MD

Hans Kaanders, Prof., PhD, MD

Management of the neck in Wang cT1-T2N0 nasal vestibule carcinoma (NVC) has been an ongoing point of discussion. As the disease is rare publications are scarce and published regional recurrence rates vary widely between 0% up to 23%. In general, literature recommends adequate radiological neck staging followed by a watchful waiting policy, as overall regional recurrence rates are low (5-10%).

However, according to recent findings, a subset of patients with large or voluminous cT1-T2N0 NVC is deemed at high risk of nodal involvement (20-40% regional recurrence) but receive no elective treatment, although it is well known that presence of nodal metastases impacts the prognosis of head and neck cancer (HNC) dramatically. Whereas elective neck dissection may be too aggressive, sentinel node biopsy (SNB) has been proven a reliable and safe alternative to bridge the gap between imaging and neck dissection.

SNB is currently routinely employed in most HNC centres in the Netherlands and is considered state of the art care, but its application in HNC is limited to oral cavity carcinoma and squamous cell carcinoma of the skin. Following the observation of increased risk of (occult) nodal metastases and regional recurrence in bulky tumors, the sentinel node procedure seems ideally suited for cT1-T2N0 NVC patients. Its superficial tumor localization is easily accessible for peritumoral Tc-99m-nanocolloid-ICG tracer injection. The purpose of this prospective registration study is to document the clinical introduction of the sentinel node procedure for bulky nasal vestibule carcinoma in our centre by protocol, and to identify and address possible unexpected difficulties specific for this tumor site. Ultimately, the goal will be routine and wide implementation of SNB in the NVC subgroup known to be at risk of nodal involvement, as a means to improve regional disease staging and control.

Objective: To prospectively document the introduction of the sentinel node procedure for bulky cT1-T2N0 nasal vestibule carcinoma in patients at risk of nodal involvement.

Study design: Single centre prospective registration study. To be extended with a second centre.

Study population: Patients with Wang cT1-T2N0 squamous cell carcinoma of the nasal vestibule, with tumor diameter ≥1.5 cm and/or tumor volume ≥1.5 cm3, with a WHO performance score of 2 or lower and no history of previous surgery or radiotherapy of the neck.

Interventions: 1. Subcutaneous peritumoral radioactive tracer injection followed by lymphoscintigraphy and Single Photon Emission Computed Tomography (SPECT) imaging for sentinel lymph node visualization.

2. Surgical sentinel node biopsy and histopathological examination of harvested nodes following the abovementioned imaging.

Main study parameters/endpoints: The primary endpoint of this study will be successful identification of sentinel nodes on lymphoscintigraphy and SPECT imaging. The procedure will be considered feasible when one or more sentinel nodes can be identified and localized in at least 7 out of the 10 patients..

Management of the neck in Wang cT1-T2N0 nasal vestibule carcinoma (NVC) has been an ongoing point of discussion. As the disease is rare publications are scarce and published regional recurrence rates vary widely between 0% up to 23%. In general, literature recommends adequate radiological neck staging followed by a watchful waiting policy, as overall regional recurrence rates are low (5-10%).

However, according to recent findings, a subset of patients with large or voluminous cT1-T2N0 NVC is deemed at high risk of nodal involvement (20-40% regional recurrence) but receive no elective treatment, although it is well known that presence of nodal metastases impacts the prognosis of head and neck cancer (HNC) dramatically. Whereas elective neck dissection may be too aggressive, sentinel node biopsy (SNB) has been proven a reliable and safe alternative to bridge the gap between imaging and neck dissection.

SNB is currently routinely employed in most HNC centres in the Netherlands and is considered state of the art care, but its application in HNC is limited to oral cavity carcinoma and squamous cell carcinoma of the skin. Following the observation of increased risk of (occult) nodal metastases and regional recurrence in bulky tumors, the sentinel node procedure seems ideally suited for cT1-T2N0 NVC patients. Its superficial tumor localization is easily accessible for peritumoral Tc-99m-nanocolloid-ICG tracer injection. The purpose of this prospective registration study is to document the clinical introduction of the sentinel node procedure for bulky nasal vestibule carcinoma in our centre by protocol, and to identify and address possible unexpected difficulties specific for this tumor site. Ultimately, the goal will be routine and wide implementation of SNB in the NVC subgroup known to be at risk of nodal involvement, as a means to improve regional disease staging and control.

Objective: To prospectively document the introduction of the sentinel node procedure for bulky cT1-T2N0 nasal vestibule carcinoma in patients at risk of nodal involvement.

Study design: Single centre prospective registration study. To be extended with a second centre.

Study population: Patients with Wang cT1-T2N0 squamous cell carcinoma of the nasal vestibule, with tumor diameter ≥1.5 cm and/or tumor volume ≥1.5 cm3, with a WHO performance score of 2 or lower and no history of previous surgery or radiotherapy of the neck.

Interventions: 1. Subcutaneous peritumoral radioactive tracer injection followed by lymphoscintigraphy and Single Photon Emission Computed Tomography (SPECT) imaging for sentinel lymph node visualization.

2. Surgical sentinel node biopsy and histopathological examination of harvested nodes following the abovementioned imaging.

Main study parameters/endpoints: The primary endpoint of this study will be successful identification of sentinel nodes on lymphoscintigraphy and SPECT imaging. The procedure will be considered feasible when one or more sentinel nodes can be identified and localized in at least 7 out of the 10 patients..

The secondary outcomes will be: yield of at least one lymph node after biopsy, incidence of surgical complications and pain score during and after peritumoral tracer injection and tracer.

Sentinel NOSE Study: Prospective Registration Study on the Sentinel Node Procedure for Bulky Squamous Cell Carcinoma of the Nasal Vestibule.

Sentinel NOSE Study: Prospective Registration Study on the Sentinel Node Procedure for Bulky Squamous Cell Carcinoma of the Nasal Vestibule

the number of identified nodes on SPECT that can actually be retrieved at subsequent surgery

Pain scores during and immediately after the injection of nanocolloid on a visual anlog scale ranging from 0-10

use of analgetics ( both orally and locally administered)

complications after surgery as registered in our hospital record database

Radboud University Medical Center

Enrolling all eligible endometrial cancer patient to the Sentinel node concept using indocyanine green.

Patients with Endometrial cancer undergo Sentinel node procedure using Indocyanine green

Jan Persson, Ass Prof

In endometrial cancer (EC) pelvic and paraaortic lymphadenectomy is performed only in high risk groups (with approximately 20% of patients having lymph node metastases (LNM)) whereas no lymphadenectomy is recommended in low risk groups despite 5% LNM. Moreover, preoperative risk group allocation is known to be erroneous in up to 15% of patients.

A technique identifying sentinel lymph nodes (SLN) in endometrial cancer have the potential to spare extensive surgery in 80% of high risk patients, identify low risk patients with nodal metastases, diminish side effects caused by full lymphadenectomy and render some expensive preoperative risk group allocation measures unnecessary.

A clinically useful SLN technique requires a high technical success rate, a clear definition of SLN, an algorithm taking into account that metastatic nodes not always accumulate tracer and a reproducible surgical algorithm. A definition of SLN requires knowledge on lymphatic anatomy. Unfortunately all tracers, dyes/radiotracers often result in an abundance of colored/ signaling nodes. Therefore, a definition of a SLN requires identification of efferent/afferent lymph vessels.

Several publications describe sentinel node techniques in EC with a variety of tracers (various dyes, radiotracer, alone or in combination). Sentinel nodes are usually described as "radioactive nodes" or "colored nodes" only with no further discrimination. No study relate to an anatomical description of lymphatic pathways.

The aims of this study is to systematically display the major anatomical pathways with the use of ICG and to evaluate a standardized and reproducible SLN surgical algorithm based on lymphatic anatomy and identification of efferent lymph vessels.

Endometrial cancer is an increasingly common gynecologic malignancy. The cumulative 5-year survival rate for node negative patients is 94%, 75% in those with metastatic pelvic lymph nodes only and 38% in patients with pelvic and paraaortic metastases. The proportion of node positive patients in adequately staged patient materials (usually high risk groups) is reported in the range of 15-21%. Depending on used risk criteria lymph node metastases occur in 1.5-7.8% in low risk patients. Some studies show better overall survival after pelvic and paraaortic lymphadenectomy, whereas other studies show increased complications with no survival benefit from the lymphadenectomy. Recent articles recommend paraaortic and pelvic lymp node metastases (LND) in high risk EC but the therapeutic value related to potential complications of nodal staging in EC is debated as well as how to define risk groups. An incidence of 0.9-5.2% severe lymphedema and 3.1% chylous ascites requiring treatment has been described after robotic pelvic and paraaortic lymphadenectomy.

The Sentinel node concept has been studied extensively in other cancer forms, for example breast and vulvar cancer. With the above mentioned controversy, patients with EC would benefit tremendously from a functioning Sentinel node concept. Studies using patent blue or radioactive tracer have not shown satisfactory results. The Da Vinci system (da Vinci® Surgical System, Intuitive Surgical Inc., Sunnyvale, Ca, USA) with Firefly technique could make a new concept possible in which major lymphatic drainage can be displayed and learned, hence allowing a standardization of SLN definitions. In our pilot studies, a reproducible surgical algorithm has been defined, overcoming and compensating the fact that ICG spreads quickly to several nodes.

Purpose: To develop a reliable Sentinel node Concept using the Firefly system with ICG in EC patients based on a defined lymphatic anatomy, a clear definition of a sentinel node and a reproducible surgical algorithm.

Hypothesis: The Firefly system using ICG enables the use of a Sentinel node concept in EC patients regardless risk group, so that only patients with pathologically proven lymph nodes metastases undergo a pelvic and paraaortic lymphadenectomy.

Methods of Research:

375 consecutive EC patients planned for robotic hysterectomy, bilateral salpingo-oophorectomy and in high risk patients also pelvic and paraaortic lymphadenectomy at Skane University Hospital, Lund, Sweden are enrolled in this study prospectively after giving written consent. The study is approved by the regional Institutional Review Board. With extended funding, the study will be expanded to another University Hospital in Sweden. Data on operative outcome, operative and postoperative complications, pathology reports and follow up for 24 months are prospectively collected. The use of Indocyanine green (ICG) and the Firefly system has the advantage of a fast uptake to lymphatic vessels and lymph nodes. Pilot studies have resulted in a new surgical method, standardization of operative technique and a clear definition of the Sentinel lymph node which now enables this study.

Detection of SLN followed by a complete lymphadenectomy. In this way every patients will serve as her own control

Sentinel Lymph Node Detection in Endometrial Cancer

Near Infrared Fluorescent Technique for Sentinel Lymph Node Mapping in Endometrial Cancer

The study measures the sensitivity of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases

The study measures the specificity of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases

The study measures the false negative rate of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases

The study measures the recurrence rate after concluded treatment including the Sentinel node concept

Comparison of the incidence of lymphatic complications such as lymph cysts and lymph edema after Sentinel node biopsy and full pelvic and paraaortic lymphadenectomy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour	NCT03448822	Testicular Germ...	sentinel node p...	18 Years -	The Netherlands Cancer Institute
Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour	NCT03448822	Testicular Germ...	sentinel node p...	18 Years -	The Netherlands Cancer Institute
Sentinel Node and Endometrial Cancer	NCT00987051	Endometrial Neo...	Detection of se...	18 Years -	Assistance Publique - Hôpitaux de Paris
Sentinel NOSE Study: Prospective Registration Study on the Sentinel Node Procedure for Bulky Squamous Cell Carcinoma of the Nasal Vestibule.	NCT05637307	Squamous Cell C...	Sentinel node p...	18 Years -	Radboud University Medical Center
Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour	NCT03448822	Testicular Germ...	sentinel node p...	18 Years -	The Netherlands Cancer Institute
Sentinel Lymph Node Detection in Endometrial Cancer	NCT02690259	Endometrial Neo...	Sentinel node p...	18 Years -	Region Skane

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