Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05197530

Imaging of Lymphatic Vessels in People with Rheumatoid Arthritis (RA)

Led by University of Rochester · Updated on 2025-03-20

40

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

Sponsors

U

University of Rochester

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Imaging of Lymphatic Vessels in People with Rheumatoid Arthritis (RA)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide written informed consent
  • Be 18 years old or older
  • Fulfill 2010 American College of Rheumatology criteria for Rheumatoid Arthritis with a DAS28-C-Reactive Protein (CRP) score above 3.5
  • Have early RA with disease duration of 1 year or less, or established RA with at least 10 years of disease
  • For early RA: must be methotrexate inadequate responder (DAS28-CRP >2.6 at 4 months) or experiencing a flare on methotrexate and starting anti-TNF therapy
  • For established RA: must be on a stable dose of DMARD, Janus Kinase inhibitor, or biologic agent for at least 8 weeks
  • Have active synovitis in one or both hands confirmed by ultrasound
Not Eligible

You will not qualify if you...

  • Have active systemic disorders or inflammatory conditions other than RA, including chronic hepatitis B, hepatitis C, or HIV infections
  • Have known sensitivity to iodine due to residual iodide in Indocyanine Green
  • Are pregnant (pregnancy tests will not be performed)
  • Have inability to donate blood due to poor venous access

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Rochester

Rochester, New York, United States, 14642

Actively Recruiting

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Research Team

J

Joseph Solomon, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Imaging of Lymphatic Vessels in People with Rheumatoid Arthritis (RA) | DecenTrialz