Recruiting
Phase 1

Observational Study

Sponsor:

University of Rochester

Code:

NCT05197530

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Indocyanine green

MultiSpectral Imaging System

Study Details

Brief summary:

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

Rheumatoid Arthritis

Study ID

NCT05197530

Start date

Dec 30, 2021

Status verified date

Feb, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Early RA (<1 year of disease)

In this single center study, early RA subjects (<1 year of disease) who are MTX inadequate responders or experience a flare (see inclusion criteria for detail) on MTX and are starting an anti-TNF therapy will be invited to participate to receive ICG injections at Baseline (prior to the start of medication), week 16 and week 52. NIR-ICG imaging will be done immediately post injection and 1 week later for a total of three injection/imaging visits and three imaging visits without injections. See schedule of events for more detail. Total length of participation will be up to 53 weeks (+3days).

experimental: Established RA (> 10 years of disease)

Patients with symptomatic established RA (>10 years) will be invited to participate in an ICG injections followed by NIR-ICG imaging and NIR-ICG imaging visit 1 week later. Total length of participation will be up to 1 week (+3 days)

Interventions

Indocyanine green

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

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.

Primary outcome measure

  • Clearance [ Time Frame: 1 week post injection ]

Central Contacts and Locations

Central contacts

Joseph Solomon, BS

585-275-1634joseph_solomon@urmc.rochester.edu

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Joseph Solomon, BS

585-275-1634joseph_solomon@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

May 27, 2026

Last verified

Feb, 2026

Keywords

  • Near InfraRed
  • Lymphatic Transport
  • Imaging
  • Indocyanine Green
  • ICG
  • Rheumatoid Arthritis
  • MSImager

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-05-27.