Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis

Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis - Rheumascan Pilot Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012399

Enrollment

Registered

2013-11-26

Start date

2013-10-16

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

Patients with active rheumatoid arthritis (1)Assessment of tender and swollen joints by physical examination (2)Joint ultrasonography (assessment of active synovitis by grading and quantification of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: This study recruits 3 healthy subjects and 6 patients with active rheumatoid arthritis. Healthy subjects are required to be free of history of rheumatoid arthritis and other diseases that can cause any type of arthritis. Patients with active rheumatoid arthritis must fulfill all of the following criteria. (1)2010 ACR/EULAR classification criteria for RA (2)have not experienced any change in treatment (change of DMARDs, change of doses of DMARDs or corticosteroids) in 4 weeks prior to enrollment (3)have no plan for treatment change during 2 weeks after enrollment

Exclusion criteria

Exclusion criteria: A subject with contraindication for indocyanine green (ICG), which is a past history of hypersensitivity to ICG or iodides. For patients with active rheumatoid arthritis, a subject with contraindication for MRI or gadolinium contrast (status post pacemaker implantation or other prosthetic material contraindicated for MRI, severe renal impairment [estimated GFR less than 30ml/min./m^3], a past history of severe adverse events due to MRI or gadolinium contrast). A subject who is pregnant or breast-feeding.

Design outcomes

Primary

Measure	Time frame
Specificity of Rheumascan (all 3 phases and a composite image) in healthy subjects (11 joints on each hand, total 66 joints of 3 subjects). Sensitivity of Rheumascan in active RA patients using enhanced MRI as a reference standard (2nd-5th MCP joints and a wrist of unilateral hand for each of 6 patients, total 30 joints). Comparison of Rheumascan to physical examination and ultrasonography in active RA patients (22 joints for each of 6 subjects, total 132 joints).	—

Measure

Time frame

Specificity of Rheumascan (all 3 phases and a composite image) in healthy subjects (11 joints on each hand, total 66 joints of 3 subjects). Sensitivity of Rheumascan in active RA patients using enhanced MRI as a reference standard (2nd-5th MCP joints and a wrist of unilateral hand for each of 6 patients, total 30 joints). Comparison of Rheumascan to physical examination and ultrasonography in active RA patients (22 joints for each of 6 subjects, total 132 joints).

—

Secondary

Measure	Time frame
Safety of indocyanine green (ICG) used in Rheumascan examination	—

Countries

Japan

Contacts

Public ContactFumio Hirano

Tokyo Medical and Dental University Department of Pharmacovigilance, Department of Medicine and Rheumatology

hirano.rheu@tmd.ac.jp03-5803-4677

Outcome results

None listed

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