UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062692 |
|---|---|
| Receipt number | R000071769 |
| Scientific Title | A Study to Establish Objective Evaluation Metrics for Determining Reconstruction Parameters in Deep Learning Reconstruction of Magnetic Resonance Imaging |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/26 10:25:21 |
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Basic information
Public title
A Study on Evaluation Methods for Determining Appropriate Settings for MRI Image Creation Using Deep Learning
Acronym
Evaluation Study of Appropriate Settings for MRI Image Creation Using Deep Learning
Scientific Title
A Study to Establish Objective Evaluation Metrics for Determining Reconstruction Parameters in Deep Learning Reconstruction of Magnetic Resonance Imaging
Scientific Title:Acronym
Objective Evaluation Study for Determining DLR Reconstruction Parameters in MRI
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Deep Learning Reconstruction (DLR) in MRI is useful for improving image quality and reducing scan time; however, appropriate reconstruction parameters may vary depending on the imaging sequence. In current clinical practice, reconstruction parameters are mainly determined based on visual assessment of reconstructed images, which is subjective and may have limited reproducibility. Furthermore, no objective and quantitative method for determining appropriate reconstruction parameters has yet been established. The aim of this study is to explore and develop objective evaluation metrics for determining DLR reconstruction parameters in MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Utility of objective evaluation metrics (including histogram analysis of difference images before and after DLR, SNR, and CNR) for evaluating DLR reconstruction parameters, and their association and agreement with visual assessment.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy adults aged 18 years or older at the time of informed consent.
2.Individuals with no metallic implants and no claustrophobia.
3.Individuals who have provided informed consent to participate in this study.
Key exclusion criteria
1.Individuals with metallic implants or implanted medical devices.
2.Individuals with claustrophobia.
3.Individuals who are pregnant or may be pregnant.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ito |
Organization
Fukushima Medical University
Division name
Department of Radiology and Nuclear Medicine, School of Medicine
Zip code
960-1295
Address
1 Hikariga-Oka, Fukushima 960-1295, Japan
TEL
024-547-1111
rad@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yuma |
| Middle name | |
| Last name | Takahashi |
Organization
Fukushima Medical University Hospital
Division name
Department of Radiology
Zip code
960-1295
Address
1 Hikariga-Oka, Fukushima 960-1295, Japan
TEL
024-547-1111
Homepage URL
yuma-t@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Yuma Takahashi
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
Fukushima Medical University Ethics Committee
Address
1 Hikariga-Oka, Fukushima 960-1295, Japan
Tel
0245471111
rs@fmu.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 | 09 | 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
| 2026 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study evaluating the association and agreement between objective evaluation metrics and visual assessment of DLR reconstruction parameters using phantom and healthy volunteer MRI images.
Management information
Registered date
| 2026 | Year | 08 | Month | 26 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071769
