UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061614 |
|---|---|
| Receipt number | R000070491 |
| Scientific Title | Clinical Evaluation and Protocol Optimization of a Newly Implemented Advanced Imaging Application: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/05/18 12:09:49 |
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Basic information
Public title
Clinical Evaluation and Protocol Optimization of a Newly Implemented Advanced Imaging Application: A Prospective Observational Study
Acronym
Clinical Evaluation and Protocol Optimization of a New Imaging Application
Scientific Title
Clinical Evaluation and Protocol Optimization of a Newly Implemented Advanced Imaging Application: A Prospective Observational Study
Scientific Title:Acronym
Prospective Evaluation and Optimization of Imaging Protocols for a Novel Image Generation Application
Region
| Japan |
Condition
Condition
None (Healthy adult volunteers)
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to optimize MRI examination protocols at our institution by quantitatively and qualitatively validating the efficacy of a novel imaging technology using biological images of healthy employee volunteers. Furthermore, this study aims to enhance the quality of operational workflow by systematizing this validation process, disseminate the acquired findings academically, and contribute to the widespread adoption of safe diagnostic imaging technologies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall image quality (visual evaluation using a 5-point scale or similar)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Full-time or part-time employees (healthy volunteers) belonging to the Central Radiology Department of our hospital.
Individuals aged 20 years or older at the time of informed consent.
Individuals who have provided written informed consent to participate in this study.
Key exclusion criteria
Individuals with implanted medical devices (e.g., pacemakers) that are contraindicated for MRI examinations.
Individuals with ferromagnetic metals in their body (e.g., artificial joints, surgical clips) that may affect image quality or compromise safety.
Individuals who cannot tolerate long-duration imaging inside the MRI scanner due to claustrophobia or other reasons.
Individuals who are pregnant or may be pregnant.
Individuals otherwise judged by the principal investigator or sub-investigators to be unsuitable for participation in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Nakane |
Organization
Saitama Medical University Saitama Medical Center
Division name
Radiology Department
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL
049-228-3510
jun_n@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Nakane |
Organization
Saitama Medical University Saitama Medical Center
Division name
Radiology Department
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL
049-228-3510
Homepage URL
jun_n@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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 Saitama Medical Center
Address
049-228-3510
Tel
049-228-3510
jun_n@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
| 2026 | Year | 07 | Month | 10 | 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
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pending
Management information
Registered date
| 2026 | Year | 05 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070491
