Imaging of Lymphatic Vessels in People With Rheumatoid Arthritis (RA)
ConditionRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester
About this trial
Lymphatic transport was previously examined by these investigators using Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) of the upper extremities. They established reliable and reproducible methodologies in RA patients. The purpose of this phase 2 pilot is to study RA disease progression and effectiveness as well as the mechanism of action of clinical interventions using established NIR-ICG methodologies in previous studies.
Eligibility criteria
Qualifiers
Ability to provide written informed consent
Subjects must be 18 years old or older
RA subjects must fulfill 2010 American College of Rheumatology (ACR) criteria with a DAS28-C-Reactive Protein (CRP) >3.5
Must have 1 year or less of disease
Disqualifiers
Active systemic disorders or inflammatory conditions other than RA, (i.e., 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; pregnancy tests will not be performed
Inability to donate blood due to poor venous access
Trial design
Treatments tested in this trial
- Indocyanine green
- MultiSpectral Imaging System
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Rochester
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov