Phase I Combinational Investigational New Drug Application: Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders

Trial Information

Phase I Combinational Investigational New Drug Application: Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders

Currently, there is no method to assess lymphatic function in subjects with acquired
(following surgery or trauma) or hereditary lymphedema. The causes of hereditary lymphedema
and the means to distinguish between acquired lymphedema is not available from existing
diagnostics. A method to monitor lymphatic function could assist in the development of new
therapies, prediction of subjects with susceptibility to acquire lymphedema, and evaluation
of subjects' conditions. In this Phase I trial, we conduct near-infrared fluorescence
imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the
use of a custom designed fluorescence imager to dynamically follow lymphatic trafficking in
the arms and legs of subjects. We seek to use the resulting phenotypes acquired in normal
and diseased patients to correlate to mutations of specific genes reported to be associated
with lymphatic development.