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

NCT05197530 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: STUDY68302R01AR056702-11A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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.

  1 week post injection

Secondary Outcomes (2)

• Lymphatic Vessels

  16 weeks

• Contraction Rate

  16 weeks

Study Arms (2)

Early RA (<1 year of disease)

EXPERIMENTAL

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).

Drug: Indocyanine green; Device: MultiSpectral Imaging System

Established RA (> 10 years of disease)

EXPERIMENTAL

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)

Drug: Indocyanine green; Device: MultiSpectral Imaging System

Interventions

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.

Also known as: ICG, IC-Green, 1748-701-02

Early RA (<1 year of disease); Established RA (> 10 years of disease)

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.

Also known as: MSImager

Early RA (<1 year of disease); Established RA (> 10 years of disease)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christopher Ritchlin, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Solomon, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 19, 2022
• Study Start: December 30, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

US (1)