Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Patients will undergo ICG injection and NIR imaging for lymphatic mapping. Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy. The SLN biopsy procedure will be performed as described below. Although NIR with ICG is used to assess conduit perfusion in all esophagectomies performed at MSK, its use for lymphatic mapping is considered experimental in esophageal cancer.

Patients will receive a perilesional injection of indocyanine green (ICG) before the laparoscopic phase of the esophagectomy.

Injection of indocyanine green (ICG)dye

Real-time near-infrared (NIR) fluorescence imaging will be performed by use of the Novadaq PINPOINT minimally invasive system with a laparoscopic camera.

Near-Infrared Image-Guided

Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.

Sentinel Lymph Node (SLN) mapping

Daniela Molena, MD

Smita Sihag, MD, MPH

The purpose of this study is to find out whether sentinel lymph node (SLN) mapping with ICG dye and NIR imaging can be used to identify esophageal or esophagogastric junction cancer that has spread to the lymph nodes. If SLN mapping is successful in these types of cancer, surgeons in the future could identify the sentinel lymph nodes and only remove these instead of removing all the lymph nodes which is currently done.

This will be a prospective single-arm study.

Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging

Does the Concept of the Sentinel Lymph Node Apply to Esophageal Cancer? A Prospective Assessment of Near-infrared Image-guided Lymphatic Mapping and Sentinel Lymph Node Identification in Esophageal Cancer

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Surgical data will include the number of lymph nodes identified and removed both NIRfluorescent and NIR-nonfluorescent nodes.

Memorial Sloan Kettering Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin

All patients will receive an injection of both tracers in order to detect the sentinel lymph node

99mTC nanocolloid albumin injection

ICG injection

Laura Burunat, Graduate

Berta Diaz-Feijoo, Physician

Aureli Torné, Physician

Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.

Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer

Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and Indocyanine Green (ICG) in Patients With Epithelial Ovarian Cancer in Early Stages: Pilot Study

Global detection rate of sentinel lymph node in patients having received both tracers.

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by morphologic characteristics.

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by pathology results

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by FIGO stage

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by biochemistry results

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by surgical approach

Detection rate of sentinel lymph node with 99mTC in the group of patients having received the tracer

Detection rate and false negative rate of intraoperative detector gamma probe,stratified by morphologic characteristics.

Detection rate and false negative rate of intraoperative detector gamma probe,stratified by pathology results.

Detection rate and false negative rate of intraoperative detector gamma probe,stratified by FIGO stage.

Detection rate and false negative rate of intraoperative detector gamma probe,stratified by biochemistry results.

Detection rate and false negative rate of intraoperative detector gamma probe,stratified by surgical approach.

Detection rate and false negative rate of intraoperative NIR camera,stratified by morphological characteristics

Detection rate and false negative rate of intraoperative NIR camera,stratified by pathology results.

Detection rate and false negative rate of intraoperative NIR camera,stratified by FIGO stage.

Detection rate and false negative rate of intraoperative NIR camera,stratified by biochemistry results.

Detection rate and false negative rate of intraoperative NIR camera,stratified by surgical approach.

Anatomical location of sentinel lymph node according to ICG.

Anatomical location of sentinel lymph node according to 99mTC albumin nanocolloid.

Assessment of concordance of sentinel lymph node anatomical location detected with each tracer.

Pathology ultra-staging evaluation.

The following classification will be considered according to the criteria of the American Joint Committee on Cancer (AJCC):

* Macrometastases: tumor infiltration \> 2 mm in maximum diameter.
* Micrometastases: tumor infiltration between 0.2 and 2 mm in maximum diameter.
* Isolated tumor cells or isolated cell group (CTA, GCA): clusters of cells smaller than 0.2 mm

Chirurgic and post-operative complications, directly or indirectly associated to the use of the tracers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging	NCT04400292	Esophageal Canc...	Injection of in... Near-Infrared I... Sentinel Lymph ...	18 Years -	Memorial Sloan Kettering Cancer Center
Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer	NCT05937620	Ovarian Epithel...	99mTC nanocollo... ICG injection	18 Years -	Fundacion Clinic per a la Recerca Biomédica
Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging	NCT04400292	Esophageal Canc...	Injection of in... Near-Infrared I... Sentinel Lymph ...	18 Years -	Memorial Sloan Kettering Cancer Center

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