UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059249 |
|---|---|
| Receipt number | R000067770 |
| Scientific Title | Clinical Evaluation of Deep Learning Based Acceleration of Three Dimensional Abdominal MRI Sequences |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/30 21:27:43 |
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Basic information
Public title
Evaluation of Deep Learning Accelerated Three Dimensional Magnetic Resonance Imaging in the Abdomen
Acronym
DL-Speed MRI
Scientific Title
Clinical Evaluation of Deep Learning Based Acceleration of Three Dimensional Abdominal MRI Sequences
Scientific Title:Acronym
DL-Speed MRI
Region
| Japan |
Condition
Condition
Abdominal diseases (various)
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the clinical utility of three dimensional abdominal MRI sequences incorporating DL Speed, a deep learning based acceleration technique, by comparing them with conventional three dimensional sequences added to standard imaging protocols.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The image quality of accelerated three-dimensional MRI sequences will be compared with that of conventional sequences, both quantitatively and qualitatively. For quantitative assessment, commonly used parameters in MRI image quality evaluation, such as signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), will be measured. For qualitative assessment, multiple investigators will perform visual evaluations and scoring for comparison.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Both the DL Speed-accelerated sequence and the conventional sequence will be obtained during the same examination and comparatively evaluated
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
Outpatients at Keio University Hospital scheduled to undergo abdominal MRI examinations that include three-dimensional sequences in the imaging protocol.
Key exclusion criteria
Individuals under 18 years of age
Pregnant women or those with possible pregnancy
Patients with electrically, magnetically, or mechanically activated implanted devices (e.g., pacemakers)
Patients considered intolerant of prolonged examinations due to conditions such as claustrophobia
Any other individuals deemed unsuitable by the principal investigator or co-investigators
Target sample size
393
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Tsuzaki |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-3353-1211
jtsuzaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Tsuzaki |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
jtsuzaki@rad.med.keio.ac.jp
Sponsor or person
Institute
Keio University
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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 | 10 | 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 | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | 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
| 2025 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067770
