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Fluorescence Imaging Evaluation of Rheumatoid Arthritis Synovitis Using the Fluorescent Dye Indocyanine Green (ICG)

Fluorescence Imaging Evaluation of Rheumatoid Arthritis Synovitis Using the Fluorescent Dye Indocyanine Green (ICG) - Fluorescence Imaging Evaluation of Rheumatoid Arthritis Synovitis Using the Fluorescent Dye Indocyanine Green (ICG)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051250097
Enrollment
63
Registered
2025-08-28
Start date
2025-08-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

After obtaining written consent from the study participants, the investigational drug indocyanine green will be administered intravenously within 100 days of consent acquisition. The observation sites

Sponsors

Kotani Takuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Rheumatoid arthritis patients Patients with rheumatoid arthritis over 18 years of age Patients with typical Heberden's nodes, Bouchard deformities, or osteophyte formation on hand X-rays Patients diagnosed with rheumatoid arthritis based on the 2010 ACR criteria Those who have received sufficient explanation for participating in this study and have obtained written consent of their own free will after sufficient understanding. Osteoarthritis of the hand patients Patients aged 18 and older diagnosed with osteoarthritis of the hand. Patients with typical Heberden's nodes, Bouchard deformities, or osteophyte formation on hand X-rays Those who do not suffer from rheumatoid arthritis Those who have received sufficient explanation for participating in this study and have obtained written consent of their own free will after sufficient understanding. Healthy Individuals Those who are 18 years of age or older Those who do not suffer from rheumatoid arthritis Those who do not suffer from osteoarthritis Those who have received sufficient explanation for participating in this study and have obtained written consent of their own free will after sufficient understanding.

Exclusion criteria

Exclusion criteria: Those who have a history of allergy to ICG. Pregnant or breastfeeding women. Those who have severe cardiovascular or liver disease. Any other patients who are judged to be inappropriate for the study by the principal investigator (co-investigator).

Design outcomes

Primary

MeasureTime frame
Quantitative evaluation of synovitis using ICG fluorescence Imaging (including comparison of values in rheumatoid arthritis patients with those in healthy Individuals and osteoarthritis of the hand patients)

Secondary

MeasureTime frame
Correlation between the quantitative evaluation values of synovitis using ICG fluorescence imaging and the assessment of affected joints through X-ray and joint inflammation evaluation using ultrasound. Correlation between the quantitative evaluation values of synovitis using ICG fluorescence imaging and the assessment of disease activity in rheumatoid arthritis (DAS28-CRP, DAS28-ESR, CDAI, SDAI) and AD(HAQ).

Contacts

Public ContactTakuya Kotani

Osaka Medical and Pharmaceutical University Hospital

takuya.kotani@ompu.ac.jp+81-72-683-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026