Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
20

Summary

Conditions
Rheumatoid Arthritis
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention 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

Participation Requirements

Age
Between 18 years and 89 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT02680067
Collaborators
  • National Institutes of Health (NIH)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Christopher Ritchlin, MD/MPH University of Rochester