NIR Fluorescence Imaging of Lymphatic Transport Using ICG

Lymphedema from various etiologies (i.e. infection, cancer, surgery, and rheumatoid
arthritis) remains a major health concern. Efforts to develop effective treatments for this
condition have been limited by the absence of quantitative outcome measures for lymphatic
function. Published articles have supported the fact that human lymphatic contractions can be
readily visualized after intradermal administration of micrograms of Indocyanine Green using
laser-induced fluorescence. The use of lasers imposes a risk of eye injury that requires
protective eyewear. To address the risk of laser-induced injury, an imaging system was
developed by Drs. Ronald Wood and Jay Reeder in a collaborative effort at the University of
Rochester. In place of a laser, this system utilizes a tungsten-halogen lamp fitted with a
bandpass filter and a multispectral camera for real-time image acquisition and display. This
phase 1 study will examine the validity and reliability of this instrument to measure
lymphatic transport, contractions, and pressure in the arms of healthy research subjects and
establish baseline parameters for subsequent evaluation of rheumatoid arthritis patients in
later studies. Indocyanine Green is a dye that has been used clinically for over 50 years to
evaluate hepatic clearance, cardiovascular function testing, and retinal angiography.
Indocyanine Green has typically been administered intravenously at concentrations of 2.5
mg/ml at total doses of 25 mg in adults. In this study, intradermal administration of
micrograms of Indocyanine Green will be used to establish useful dose ranges and
concentrations. The dosage regimen for this study is based on prior demonstrations in
published articles of successful noninvasive imaging of lymphatic contractions after
intradermal administration of microgram amounts of Indocyanine Green.

Inclusion Criteria:

- Ability to provide written informed consent

- Subjects can be either gender but must be at least 18 years old.

- Rheumatoid arthritis subjects may fulfill 2010 American College of Rheumatology
criteria.

- Active rheumatoid arthritis subjects, with at least 2 tender or swollen joints.

- Subjects participating in the clearance arm of the study must not have ICG injections
for at least 10 weeks.

Exclusion Criteria:

- Individuals with active systemic disorders or inflammatory conditions other than
rheumatoid arthritis, (such as chronic infections with hepatitis B, hepatitis C or
HIV) that would confound the study results.

- Known sensitivity to iodine because of residual iodide in Indocyanine Green

- Pregnant women should not participate.