The purpose of this study is to demonstrate the feasibility of near-infrared fluorescence
imaging in subjects with acquired or hereditary lymphedema, in subjects with lipidema and
other lymphovascular disorders and in normal health subjects; in order to attempt to
correlate imaging phenotype(s) with genotype(s).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00833599.
Locations matching your search criteria
United States
Texas
Houston
The University of Texas Health Science Center, HoustonStatus: Enrolling By Invitation
Contact: Eva M Sevick
Phone: 713-500-3560
Currently, there is no method to assess lymphatic function in persons with acquired
(developed following surgery or trauma) lymphedema, hereditary lymphedema or other
lympho-vascular disorders. The causes of these disorders, and the means to distinguish
between them, is not available from existing diagnostics. A method to monitor lymphatic
function could assist in the development of new therapies, the prediction of a patient's
susceptibility to develop these disorders, and the evaluation of patient's conditions or
responses to therapy and treatment. In this Phase I/II trial, we inject Indocyanine Green
(ICG) off-label as a lymph contrast agent and use a custom designed fluorescence imager
to conduct near-infrared fluorescence imaging to dynamically follow lymphatic trafficking
in subjects. Blood is also collected for DNA analysis. The resulting images are analyzed,
and the phenotypes observed in both normal and diseased subjects are used to correlate to
mutations of specific genes reported to be associated with lymphatic development.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationThe University of Texas Health Science Center, Houston
Principal InvestigatorEva M Sevick
