UMIN-CTR Clinical Trial

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
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Purpose of intervention
Type of intervention
Interventions/Control_1
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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 Tamotsu Middle name Last name Kamishima
Organization	Hokkaido University
Division name	Faculty of Health Sciences
Zip code	060-0812
Address	North-12, West-5, Kita-ku, Sapporo , Japan
TEL	011-706-2824
Email	ktamotamo2@hs.hokudai.ac.jp

Public contact
Name of contact person	1st name Tamotsu Middle name Last name Kamishima
Organization	Hokkaido University
Division name	Faculty of Health Sciences
Zip code	060-0812
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
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hokkaido University
Address	North-12, West-5, Kita-ku, Sapporo 060-0812, Japan
Tel	+81117063315
Email	ktamotamo2@hs.hokudai.ac.jp

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
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Results
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IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 01 Day
Date of IRB	2017 Year 10 Month 01 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2018 Year 11 Month 10 Day
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	2021 Year 10 Month 13 Day

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