NIR Fluorescence Imaging of Lymphatic Transport Using ICG
- Conditions
- Rheumatoid Arthritis
- Interventions
- Device: MultiSpectral Imaging System
- Registration Number
- NCT02680067
- Lead Sponsor
- University of Rochester
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Developmental arm - Healthy or rheumatoid arthritis subjects MultiSpectral Imaging System Subjects in the developmental arm will have a minimum of two study visits to determine the optimal conditions for visualizing lymphatic transport in the upper extremities. Concentrations of 0.1 mg/ml of Indocyanine Green (ICG) will be injected intradermally into the web spaces of the hands in both upper extremities. Multispectral video and still images will be recorded using the MultiSpectral Imaging System (MSImager). An ultrasound of the upper extremities may be performed after the ICG fluorescence is observed. The exam will help identify the location of the lymphatic vessels and nodes in the areas fluoresced. Developmental arm - Healthy or rheumatoid arthritis subjects Indocyanine Green Subjects in the developmental arm will have a minimum of two study visits to determine the optimal conditions for visualizing lymphatic transport in the upper extremities. Concentrations of 0.1 mg/ml of Indocyanine Green (ICG) will be injected intradermally into the web spaces of the hands in both upper extremities. Multispectral video and still images will be recorded using the MultiSpectral Imaging System (MSImager). An ultrasound of the upper extremities may be performed after the ICG fluorescence is observed. The exam will help identify the location of the lymphatic vessels and nodes in the areas fluoresced. Clearance arm - Healthy individuals Indocyanine Green Subjects in the clearance arm will have an initial study visit that involves injections of 0.1 mg/ml of Indocyanine Green (ICG) intradermally into the web spaces of the hands in both upper extremities. Multispectral video and still images will be recorded using the MultiSpectral Imaging System (MSImager). Follow up imaging sessions will occur weekly for three weeks for a minimum of four study visits total.
- Primary Outcome Measures
Name Time Method Contraction Rate 36 months The contraction rate is measured as lymphatic vessel contractions/min in the dominant lymphatic vessel efferent to the injection site using the MultiSpectral Imaging System (MSImager) that captures real time movies. The MSImager software analyses the signal intensity to determine the contraction rate.
- Secondary Outcome Measures
Name Time Method Lymphatic Pressure 36 months The lymphatic pressure is measured using a transparent cuff and the Multispectral Imaging System to determine indirect lymphatic pressure and recorded as mm Hg.
Trial Locations
- Locations (1)
University of Rochester
🇺🇸Rochester, New York, United States