drugset / Trial / NCT01295931

Nuclear and Near-Infrared (NIR) Imaging in Melanoma

NCT01295931

NaSingle-groupOpen-labelDiagnostic

Summary

Objectives: 1. To determine the feasibility of using microdose amounts of near-infrared (NIR) fluorescent contrast agent to image tumor-draining and contralateral lymphatics in melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion lymph node dissection (axillary or inguinofemoral) 2. To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to characterize lymphatic architecture and function by correlating the observed lymphatic structure and function with tumor and nodal status as determined from standard-of-care immunohistochemical evaluation.

Timeline

Start
2011-02
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Indocyanine Green Diagnostic / imaging agent 25 ug Other
Subject Indocyanine Green Diagnostic / imaging agent 0.1 ml Other

Indications