UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056600 |
|---|---|
| Receipt number | R000064685 |
| Scientific Title | Wrist MRI Reconstruction: AI Reconstruction and Microscopy Coil Comparison with Traditional Methods |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/12/30 09:03:45 |
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Basic information
Public title
Evaluation of Artificial Intelligence (AI)-Based Image Reconstruction Methods for Wrist MRI
Acronym
Wrist AI Reconstruction Evaluation
Scientific Title
Wrist MRI Reconstruction: AI Reconstruction and Microscopy Coil Comparison with Traditional Methods
Scientific Title:Acronym
AI Reconstruction Evaluation / Effect of Coil
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare image quality in wrist MRI of healthy volunteers with changes in image reconstruction methods and receiver coils.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wrist MRI
Proton Density Weighted Image (PDWI)
T2*-Weighted Image (T2*-WI)
Magnetic Resonance Angiography(MRA)
Key secondary outcomes
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
In healthy subjects, wrist MRI imaging will be performed under standard conditions, followed by imaging using AI Reconstruction (AI-CS SENSE). Additionally, imaging will be performed using microscopy coils under the same conditions.
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women aged 20 to 40 with written informed consent
Key exclusion criteria
1. People who have a history of injury, treatment, or surgery in the hand, or who have been noted for any abnormalities.
2.Cases corresponding to MRI contraindication.
3. Those who may be pregnant
4. Cases in which MRI artifacts are likely to appear and signal values are difficult to measure.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kondo |
Organization
Saitama Medical University Hospital
Division name
Department of Radiology
Zip code
350-0495
Address
38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-2021
ak032ch@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Yamagishi |
Organization
Saitama Medical University Hospital
Division name
Department of Radiology
Zip code
350-0495
Address
38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1586
Homepage URL
yamagishi.jun@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Hospital
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
Saitama Medical University Hospital
Address
38 Morohongou, Moroyama-machi, Iruma-gun, Saitama
Tel
049-276-1354
hirb@saitama-med.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
| 2025 | Year | 01 | Month | 06 | 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
12
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
| 2025 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064685
