UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034452
Receipt number 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 2021/10/13 09:10:34

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

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 or person

Institute

Hokkaido University

Institute

Department

Personal name



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

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039283


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name