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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Indocyanine green

    Drug

    A trained physician will inject 0.1 ml of the ICG in to the web spaces of the hands in both upper extremities.

  • MultiSpectral Imaging System

    Device

    Once the ICG is injected, the contrast is expected to fluoresce underneath the MultiSpectral Imaging System. Multispectral video and still images will be recorded at the study visits.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Early RA (<1 year of disease)Experimental treatment 2 interventions
Group B: Established RA (> 10 years of disease)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Clearance

The change in Indocyanine Green signal intensity (arbitrary units) over time is measured by observing the fluorescence using the Multispectral Imaging System. The MSImager software analyses the signal intensity. This outcome measure will be quantified for both early RA and late RA subjects.

Time frame
1 week post injection

Secondary outcomes

1

Lymphatic Vessels

Using 2D still images from the NIR scanning sessions, lymphatic vessel location will be identified, and vessel numbers will be quantified. Comparisons with 2D images will be performed to identify vessel location and numbers. The images will then be superimposed upon each other in order to confirm concordance of lymphatic vessels. This outcome measure will be quantified for both early RA and late RA subjects.

Time frame
16 weeks
2

Contraction Rate

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. This outcome measure will be quantified for both early RA and late RA subjects.

Time frame
16 weeks

Other outcomes

Sponsors and contacts

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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
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