NCT05197530RecruitingPhase 1
Imaging of Lymphatic Vessels in People With Rheumatoid Arthritis (RA)
Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green: Phase II Pilot
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 3 Jan 2022
- Start date
- 30 Dec 2021
- Primary completion date
- Jun 2026
- Lead sponsor
- University of Rochester
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05197530
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 30 Dec 2021 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.