UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057207 |
|---|---|
| Receipt number | R000065391 |
| Scientific Title | Examination for distortion reduction in finger DWI of the fingers using glass beads. |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/04 21:07:13 |
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Basic information
Public title
A study on reducing distortion in DWI for MRI of the fingers using glass beads.
Acronym
A study on reducing distortion in DWI for MRI of the fingers using glass beads.
Scientific Title
Examination for distortion reduction in finger DWI of the fingers using glass beads.
Scientific Title:Acronym
Examination for distortion reduction in finger DWI of the fingers using glass beads.
Region
| Japan |
Condition
Condition
Healty volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to reduce distortion of DWI of fingers by using glass beads in the magnetic field homogeneity support pad, reduce the burden of re-imaging, and improve image quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distortion rate of DWI obtained from hand MRI examination.
Key secondary outcomes
Measurements obtained using MRI measurement tools and analysis software (ImageJ).
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
| Device,equipment |
Interventions/Control_1
An MRI examination of the fingers will be conducted only once between March 6, 2025 and April 30, 2025.
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those without abnormalities in their fingers.
Key exclusion criteria
Those who cannot maintain their position during the examination.
Those who were deemed difficult to undergo an MRI examination based on the MRI questionnaire.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | shun |
| Middle name | |
| Last name | ozaki |
Organization
Nanpuh Hospital
Division name
Radiological Technology department
Zip code
892-8512
Address
14-3 Nagata,Kagoshima-shi,Kagoshima,Japan
TEL
099-226-9111
daihyou@nanpuh.or.jp
Public contact
Name of contact person
| 1st name | shun |
| Middle name | |
| Last name | ozaki |
Organization
Nanpuh Hospital
Division name
Radiological Technology department
Zip code
892-8512
Address
14-3 Nagata,Kagoshima-shi,Kagoshima,Japan
TEL
099-226-9111
Homepage URL
daihyou@nanpuh.or.jp
Sponsor or person
Institute
Nanpuh Hospital
Institute
Department
Personal name
shun ozaki
Funding Source
Organization
None
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
Ethics Review Committee in Nanpuh Hospital
Address
14-3 Nagata,Kagoshima-shi,Kagoshima,Japan
Tel
099-226-9111
daihyou@nanpuh.or.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 | 04 | Month | 01 | 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
| 2025 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065391
