NIR Fluorescence Imaging of Lymphatic Transport Using ICG (NIR-ICG)
Rheumatoid Arthritis
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Healthy Individual, Lymphatic Transport, Near InfraRed, Imaging, Indocyanine Green, ICG, NIR, NIR-ICG, MSImager, rheumatoid arthritis
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.
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Developmental arm - Healthy or rheumatoid arthritis subjects
Clearance arm - Healthy individuals
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.
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.