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 |
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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
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
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
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
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
