Sentinel Lymph Node Mapping in Esophageal Cancer Using ICG Dye and NIR Imaging
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04400292|
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Other: Injection of indocyanine green (ICG)dye Device: Near-Infrared Image-Guided Procedure: Sentinel Lymph Node (SNL) mapping||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This will be a prospective single-arm study.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 20, 2020|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
Experimental: SLN mapping by NIR with ICG
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.
Other: Injection of indocyanine green (ICG)dye
Patients will receive a perilesional injection of indocyanine green (ICG) before the laparoscopic phase of the esophagectomy.
Device: Near-Infrared Image-Guided
Real-time near-infrared (NIR) fluorescence imaging will be performed by use of the Novadaq PINPOINT minimally invasive system with a laparoscopic camera.
Procedure: Sentinel Lymph Node (SNL) mapping
Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.
- The number of lymph nodes visualized to be fluorescent and nonfluorescent. [ Time Frame: 1 year ]Surgical data will include the number of lymph nodes identified and removed both NIRfluorescent and NIR-nonfluorescent nodes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400292
|Contact: Daniela Molena, MDfirstname.lastname@example.org|
|Contact: Smita Sihag, MD, MPH||212-639-3309|
|United States, New York|
|Memorial Sloan Kettering Cancer Center (All Protocol Activities)||Recruiting|
|New York, New York, United States, 10065|
|Contact: Daniela Molena, MD 212-639-3870|
|Principal Investigator:||Daniela Molena, MD||Memorial Sloan Kettering Cancer Center|