NIR Fluorescence Imaging of Lymphatic Transport Using ICG
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      In this phase 1 study, the lymphatic transport will be examined using Near InfraRed
      Indocyanine Green fluorescence imaging (NIR-ICG) of the upper extremities in healthy
      individuals using a MultiSpectral Imaging System (MSImager).
    

Detailed description: 
      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.
    

Intervention name(s): Indocyanine Green; MultiSpectral Imaging System
Intervention type(s): Drug; Device
Intervention description(s): A trained physician will inject 0.1 ml of Indocyanine Green into the web spaces of the hands in both upper extremities. Subjects may have up to five study visits to confirm feasibility, safety, and reproducibility.; Once the Indocyanine Green is injected, the contrast is expected to fluoresce underneath the MultiSpectral Imaging System. Multispectral video and still images will be recorded at the study visits.
Other intervention name(s): ICG; IC-Green; 17478-701-02; MSImager
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Healthy individuals and subjects that have rheumatoid arthritis may participate in the developmental arm. Healthy individuals may participate in the clearance arm. There will be no randomization.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Individual; Lymphatic Transport; Near InfraRed; Imaging; Indocyanine Green; ICG; NIR; NIR-ICG; MSImager; rheumatoid arthritis