NIR-Guided Sentinel Lymph Node Mapping in Melanoma

Completed · Phase 1

Conditions studied: Melanoma

In brief

This study will try to define an appropriate dose of the investigational drug indocyanine green (ICG) in combination with near infrared (NIR) imaging to use for future studies. ICG is a dye which has been in use since the 50s, and is approved for testing liver function and measuring blood flow from the heart. It has been used in studies to map lymphatic pathways in lung and breast cancer and information from those studies suggest it may help identify lymph nodes associated with melanoma. ICG can be detected within the body using near-infrared light cameras. In this study the investigators are looking at how easily ICG can get to the first lymph node (sentinel lymph node \[SLN\]) associated with melanoma, whether the investigators can see the path of the ICG and the SLN using a near infrared camera, and what dose of ICG works the best. While the current method for SNL mapping, known as lymphoscintigraphy, is effective it does provide a small amount of radiation. This study will compare the investigators results to the standard procedure.

Key facts

Study ID

NCT01121718

Run by

Dana-Farber Cancer Institute

People needed

26

Starts

2010-09-01

Expected to finish

2012-04-01

Last updated by the study team

2017-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed melanoma and an appropriate surgical candidate for a sentinel lymph node biopsy
• Stage of disease conducive to sentinel lymph node biopsy as determined by oncologic surgeon
• Receiving a planned lymphoscintigraphy procedure

You may not qualify if…

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of iodide or seafood allergy
• Pregnant or breast-feeding

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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