UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012399 |
|---|---|
| Receipt number | R000014498 |
| Scientific Title | Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis |
| Date of disclosure of the study information | 2013/11/26 |
| Last modified on | 2014/05/12 09:44:07 |
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Basic information
Public title
Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis
Acronym
Rheumascan Pilot Study
Scientific Title
Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis
Scientific Title:Acronym
Rheumascan Pilot Study
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare basic characteristics and diagnostic performances of Rheumascan, a fluorescence optical imaging device for arthritis in hands, to physical examination, joint ultrasonography and enhanced MRI in patients with active rheumatoid arthritis and healthy subjects. Based on findings of this study, further studies either cross-sectional or longitudinal, are intended.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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).
Key secondary outcomes
Safety of indocyanine green (ICG) used in Rheumascan examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
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 vascularity using power Doppler or color Doppler ultrasonography) in 22 joints of bilateral hands
(3)Gadolinium-enhanced MRI of the hand with more severe arthritis
(4)Examination by Rheumascan, a fluorescence optical imaging device using intravenous indocyanine green (ICG)
Interventions/Control_2
Healthy subjects
(1)Assessment of tender and swollen joints by physical examination
(2)Joint ultrasonography (assessment of active synovitis by grading and quantification of vascularity using power Doppler or color Doppler ultrasonography) in 22 joints of bilateral hands
(3)Examination by Rheumascan, a fluorescence optical imaging device using intravenous indocyanine green (ICG)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Harigai |
Organization
Tokyo Medical and Dental University
Division name
Department of Pharmacovigilance, Department of Medicine and Rheumatology
Zip code
Address
5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
TEL
03-5803-4677
mharigai.mpha@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumio Hirano |
Organization
Tokyo Medical and Dental University
Division name
Department of Pharmacovigilance, Department of Medicine and Rheumatology
Zip code
Address
5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
TEL
03-5803-4677
Homepage URL
hirano.rheu@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Department of Pharmacovigilance, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Diagnostic Imaging Center, Ochanomizu Surugadai Clinic
Name of secondary funder(s)
Meditec Far East Inc. (providing Rheumascan)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科歯科大学医学部附属病院(東京)、お茶の水駿河台クリニック(東京)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 25 | Day |
Last modified on
| 2014 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014498
