UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056152 |
|---|---|
| Receipt number | R000064159 |
| Scientific Title | The Utility of MRI Cortical Imaging for the Evaluation of the Sacroiliac Joint in Patients with Spondyloarthritis |
| Date of disclosure of the study information | 2024/11/14 |
| Last modified on | 2024/11/14 10:44:52 |
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Basic information
Public title
The Utility of MRI Cortical Imaging for the Evaluation of the Sacroiliac Joint in Patients with Spondyloarthritis
Acronym
The Utility of MRI Cortical Imaging for the Evaluation of the Sacroiliac Joint in Patients with Spondyloarthritis
Scientific Title
The Utility of MRI Cortical Imaging for the Evaluation of the Sacroiliac Joint in Patients with Spondyloarthritis
Scientific Title:Acronym
The Utility of MRI Cortical Imaging for the Evaluation of the Sacroiliac Joint in Patients with Spondyloarthritis
Region
| Japan |
Condition
Condition
spondyloarthritis
Classification by specialty
| Clinical immunology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe morphological changes in sacroiliitis in SpA patients using MRI cortical bone imaging and to verify its non-inferiority compared to CT. Simultaneously, appropriate parameters for cortical bone imaging, as well as potential new insights or methodologies in imaging diagnostics, will be explored.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In each MRI sequence, the presence or absence of characteristic SpA findings such as bone erosion, ankylosis, fat degeneration, and bone buds - will be evaluated. The concordance rate, sensitivity, and specificity between sequences will then be calculated.
Key secondary outcomes
If CT images are available, similar comparisons and analyses will also be performed using CT. To support the primary evaluation items, SNR and CNR will be calculated for each sequence, and these quantitative values will be compared and examined.
Exploratory evaluation items (and their indicators/evaluation methods): Appropriate parameters for cortical bone imaging, as well as potential new insights or methodologies in imaging diagnostics, will be visually and qualitatively assessed.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI cortical bone imaging
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older with spondyloarthritis who were referred for sacroiliac joint MRI by the Rheumatology and Collagen Disease Department based on the need for imaging evaluation.
Key exclusion criteria
- Individuals under 18 years of age
- Individuals unsuitable for MRI (e.g., those with metal implants such as pacemakers, claustrophobia, etc.)
- Individuals who do not consent to participate in the study
- Individuals who are pregnant or may be pregnant
- Individuals deemed unsuitable by the principal or co-investigators
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Nozaki |
Organization
Keio University, School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
nozaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Hase |
Organization
Keio University, School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
hase@rad.med.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
keio@esct.bvits.com
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
| 2024 | Year | 11 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064159
