Imaging lymphatic vessels in people with rheumatoid arthritis
Official title: Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green: Phase II Pilot
Run by University of Rochester · NCT05197530 · Data updated 2026-11-12
This study is testing a special imaging technique to see how well treatments work for people with rheumatoid arthritis by looking at changes in their lymphatic vessels over time.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Rochester, New York) |
| Status | Recruiting |
| Started | December 30, 2021 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | May 27, 2026 |
| Trial ID | NCT05197530 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include early RA patients with active synovitis who are inadequate responders to methotrexate or established RA patients with at least 10 years of disease.
✕Probably not a fit
Patients with RA who do not have active synovitis or those who are not starting anti-TNF therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to investigate the progression of rheumatoid arthritis (RA) and the effectiveness of clinical interventions using Near InfraRed Indocyanine Green (NIR-ICG) fluorescence imaging. The study will assess the correlation between the clearance of ICG and clinical responses in early and established RA patients undergoing anti-TNF therapy. Participants will undergo imaging at baseline, 16 weeks, and one year post-treatment to evaluate changes in lymphatic transport and synovitis. The methodology builds on previous findings that linked ICG clearance with treatment outcomes in RA patients.
Why it matters
Potential benefit: If successful, this study could provide insights into the mechanisms of RA progression and improve treatment strategies for patients.
How similar studies have gone: Previous studies have shown promising results using NIR-ICG imaging in RA, indicating that this approach has potential clinical utility.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Early RA * 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 * Must be MTX inadequate responder (DAS28-CRP \>2.6 at 4 months of therapy) OR experience a flare on MTX (self-reported and score of \>25 on the Outcome Measures in Rheumatology (OMERACT) Flare questionnaire AND are starting an anti-TNF therapy. * Must have active synovitis in one or both hands confirmed by ultrasound Established RA * Ability to provide written informed consent * Subjects must be 18 years of age or older * RA subjects must fulfill 2010 ACR criteria with a DAS-CRP \>3.5 * Must have at least 10 years of disease * Must have active synovitis in one or both hands confirmed by ultrasound * Must be on a stable dose of DMARD (MTX, leflunomide, azulfidine, hydroxychloroquine), Janus Kinase (JAK) inhibitor or biologic agent for 8 weeks Exclusion Criteria: All PATIENTS * 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
Where it's running
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University of Rochester
Rochester, New York, United States Recruiting
Study contacts
- Principal investigator: Christopher Ritchlin, MD, MPH — University of Rochester
- Study coordinator: Joseph Solomon, BS
- Email: joseph_solomon@urmc.rochester.edu
- Phone: 585-275-1634
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.