40 Participants Needed

NIR-ICG Imaging for Rheumatoid Arthritis

JS
Overseen ByJoseph Solomon, BS
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Rochester
Must be taking: DMARDs, JAK inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, if you have established RA, you must be on a stable dose of certain medications for at least 8 weeks before joining.

What data supports the effectiveness of the treatment Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) for rheumatoid arthritis?

Research shows that Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) can effectively detect joint inflammation and synovitis (inflammation of the joint lining) in rheumatoid arthritis, often performing better or comparably to traditional imaging methods like MRI.12345

Is NIR-ICG imaging safe for humans?

Indocyanine green (ICG) is generally safe for use in humans, with rare adverse reactions that can include toxic or hypersensitivity responses. It is commonly used in medical imaging, such as in eye procedures, and has been studied for imaging inflammation in arthritis.16789

How does NIR-ICG imaging differ from other treatments for rheumatoid arthritis?

NIR-ICG imaging is unique because it uses near-infrared fluorescence to detect joint inflammation, which can provide early diagnosis and treatment of rheumatoid arthritis without the need for traditional contrast agents or specialist interpretation, unlike many current imaging techniques.12346

What is the purpose of this trial?

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.

Research Team

CR

Christopher Ritchlin, MD, MPH

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for adults with early or established Rheumatoid Arthritis (RA) who meet specific criteria, including being on a stable dose of certain RA medications. They must have active joint inflammation in their hands confirmed by ultrasound and not be pregnant or have other systemic disorders that could affect the study.

Inclusion Criteria

Established RA: Ability to provide written informed consent
I have early RA, didn't respond well to MTX, or it flared up, and I'm starting anti-TNF therapy.
I have been diagnosed with rheumatoid arthritis and my disease activity is high.
See 9 more

Exclusion Criteria

I do not have chronic infections like hepatitis B, C, or HIV that could affect the study.
All Patients: Inability to donate blood due to poor venous access
All Patients: Known sensitivity to iodine because of residual iodide in Indocyanine Green
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants receive ICG injections and undergo NIR-ICG imaging at baseline prior to the start of anti-TNF therapy

1 week
1 visit (in-person)

Treatment and Imaging

Participants receive anti-TNF therapy and undergo NIR-ICG imaging at 16 weeks and 1 year post-treatment

52 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Indocyanine green
  • MultiSpectral Imaging System
Trial Overview The trial is testing how well Indocyanine Green, used with a MultiSpectral Imaging System, can track lymphatic vessel function in RA patients. It aims to understand disease progression and response to treatments using imaging techniques developed in earlier research.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Established RA (> 10 years of disease)Experimental Treatment2 Interventions
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)
Group II: Early RA (<1 year of disease)Experimental Treatment2 Interventions
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+

Findings from Research

A new 3D printing technique has been developed to create stable, anatomically accurate hand and finger models that mimic the fluorescence properties of indocyanine green (ICG), which is important for imaging in rheumatoid diseases.
Phantoms made with the fluorescent dye Lumogen IR 765 demonstrated excellent photostability for up to 4 years, significantly outperforming ICG-based phantoms that degraded over time, making them ideal for long-term imaging applications.
3D-printed tissue-simulating phantoms for near-infrared fluorescence imaging of rheumatoid diseases.Schädel-Ebner, S., Hirsch, O., Gladytz, T., et al.[2022]
The ICG-enhanced optical imaging system demonstrated a sensitivity of only 39.6% for detecting synovitis compared to contrast-enhanced MRI, indicating it may miss many cases of inflammation, especially mild synovitis.
However, the optical imaging system showed a higher specificity of 85.2%, meaning when it did indicate synovitis, it was often correct, particularly in cases of severe inflammation.
Detection of synovitis in the hands of patients with rheumatologic disorders: diagnostic performance of optical imaging in comparison with magnetic resonance imaging.Meier, R., Thürmel, K., Moog, P., et al.[2022]
Near-infrared (NIR) fluorescence imaging using ICG-lactosomes can effectively detect joint inflammation in a mouse model of rheumatoid arthritis, showing higher fluorescence in arthritic joints compared to normal ones.
Unlike ICG alone, which quickly cleared from the body, ICG-lactosomes remained in the system for at least 48 hours and specifically accumulated in inflamed joints, suggesting a potential mechanism for targeted imaging of arthritis.
Near-infrared fluorescence imaging with indocyanine green-lactosomes in a mouse model of rheumatoid arthritis.Onishi, S., Sakane, M., Tsukanishi, T., et al.[2022]

References

3D-printed tissue-simulating phantoms for near-infrared fluorescence imaging of rheumatoid diseases. [2022]
Detection of synovitis in the hands of patients with rheumatologic disorders: diagnostic performance of optical imaging in comparison with magnetic resonance imaging. [2022]
Near-infrared fluorescence imaging with indocyanine green-lactosomes in a mouse model of rheumatoid arthritis. [2022]
Fluorescence-aided tomographic imaging of synovitis in the human finger. [2015]
Fluorescence optical imaging and 3T-MRI for detection of synovitis in patients with rheumatoid arthritis in comparison to a composite standard of reference. [2018]
Inflammation assessment in patients with arthritis using a novel in vivo fluorescence optical imaging technology. [2022]
Indocyanine green-enhanced fluorescence optical imaging in patients with early and very early arthritis: a comparative study with magnetic resonance imaging. [2022]
Fluorescence optical imaging in pediatric patients with inflammatory and non-inflammatory joint diseases: a comparative study with ultrasonography. [2018]
Immediate Reactions to Fluorescein and Indocyanine Green in Retinal Angiography: Review of Literature and Proposal for Patient's Evaluation. [2022]
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