Clinical trial NCT02680067: NIR Fluorescence Imaging of Lymphatic Transport Using ICG
Official title: Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Healthy Individual
Lymphatic Transport
Near InfraRed
Imaging
Indocyanine Green
ICG
NIR
NIR-ICG
MSImager
rheumatoid arthritis
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2016-02-11
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Contraction Rate
timeFrame: 36 months
Secondary outcomes:
measure: Lymphatic Pressure
timeFrame: 36 months
Other outcomes:
measure: Clearance
timeFrame: 36 months
measure: Lymphatic Speed
timeFrame: 36 months
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Christopher Ritchlin, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahimi H, Bell R, Bouta EM, Wood RW, Xing L, Ritchlin CT, Schwarz EM. Lymphatic imaging to assess rheumatoid flare: mechanistic insights and biomarker potential. Arthritis Res Ther. 2016 Sep 1;18:194. doi: 10.1186/s13075-016-1092-0.