drugset / Trial / NCT01121718

NIR-Guided Sentinel Lymph Node Mapping in Melanoma

NCT01121718

NaSingle-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start
2010-09
Primary completion
2012-04
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Indocyanine Green Diagnostic / imaging agent 100 unknown Other
Subject Indocyanine Green Diagnostic / imaging agent 250 unknown Other
Subject Indocyanine Green Diagnostic / imaging agent 500 unknown Other

Indications