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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034452
Receipt No. R000039283
Scientific Title Intravoxel Incoherent Motion MRI for Discrimination of Synovial Proliferation in the Hand of Rheumatoid Arthritis
Date of disclosure of the study information 2018/10/12
Last modified on 2018/10/11

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Basic information
Public title Intravoxel Incoherent Motion MRI for Discrimination of Synovial Proliferation in the Hand of Rheumatoid Arthritis
Acronym MRI for Rheumatoid Arthritis
Scientific Title Intravoxel Incoherent Motion MRI for Discrimination of Synovial Proliferation in the Hand of Rheumatoid Arthritis
Scientific Title:Acronym MRI for Rheumatoid Arthritis
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test the capability of intravoxel incoherent motion (IVIM) MRI to noninvasively discriminate synovial proliferation in the hand of patients with rheumatoid arthritis (RA).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes contrast-enhanced MRI as gold standard examination
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
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Eligibility
Age-lower limit
20 years-old <
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients with suspected RA who have pain and/or swelling of the hands
Key exclusion criteria Those who are contraindicated to contrast MRI
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tamotsu Kamishima
Organization Hokkaido University
Division name Faculty of Health Sciences
Zip code
Address North-12, West-5, Kita-ku, Sapporo 060-0812, Japan
TEL 011-706-2824
Email ktamotamo2@hs.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamotsu Kamishima
Organization Hokkaido University
Division name Faculty of Health Sciences
Zip code
Address North-12, West-5, Kita-ku, Sapporo 060-0812, Japan
TEL 011-706-2824
Homepage URL
Email ktamotamo2@hs.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Hokkaido University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
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Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 12 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
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Results Delayed
Results Delay Reason
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Baseline Characteristics
Participant flow
Adverse events
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Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information IVIM will be performed using ten b values. Contrast enhanced MRI was evaluated using a grading scale of 0 to 4 according to the degree of contrast enhancement on the area indicating high signal intensity on STIR images. We will calculate the apparent diffusion coefficient value and IVIM parameters, thereafter, these parameters will be compared between synovial proliferation and joint effusion, according to the grading scale using the Spearman rank correlation test and receiver operating characteristic curve.

Management information
Registered date
2018 Year 10 Month 11 Day
Last modified on
2018 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039283

Research Plan
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Research case data specifications
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Research case data
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