UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058573 |
|---|---|
| Receipt number | R000066547 |
| Scientific Title | Artificial Intelligence-Assisted Reduction of Acquisition Time in ^123I-Ioflupane Imaging: A Retrospective Single-Center Study |
| Date of disclosure of the study information | 2025/07/25 |
| Last modified on | 2025/07/23 21:53:59 |
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Basic information
Public title
Artificial Intelligence-Assisted Reduction of Acquisition Time in 123I-Ioflupane Imaging: A Retrospective Single-Center Study
Acronym
AI-Ioflupane Study
Scientific Title
Artificial Intelligence-Assisted Reduction of Acquisition Time in ^123I-Ioflupane Imaging: A Retrospective Single-Center Study
Scientific Title:Acronym
AI-Ioflupane Study
Region
| Japan |
Condition
Condition
Parkinsonism
Classification by specialty
| Neurology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate whether acquisition time can be reduced in SPECT/CT using ^123I-ioflupane by applying AI-based image reconstruction.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the Usefulness of AI-Based Image Reconstruction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Image Quality (SNR) Between Virtual Standard-Time Acquisition Images and Standard Images
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent ^123I-ioflupane imaging
No age restriction
No sex restriction
Key exclusion criteria
Not applicalbe
Target sample size
207
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Ishiwata |
Organization
Yokohama City University Hospital
Division name
Department of Radiology
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
ishi_y@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Ishiwata |
Organization
Yokohama City University Hospital
Division name
Department of Radiology
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
Homepage URL
ishi_y@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Yokohama City University Ethics Committee for Life Science and Medical Research Involving Human Subjects
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
Tel
045-787-2800
rinri@yokohama-cu.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 | 07 | Month | 25 | 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
207
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
| 2019 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
123I-ioflupane is useful for the differential diagnosis between disorders characterized by degeneration of the nigrostriatal dopamine transporter-such as Parkinson's disease, dementia with Lewy bodies, progressive supranuclear palsy, and multiple system atrophy with parkinsonism-and other forms of parkinsonian syndromes. To obtain diagnostically appropriate images, continuous SPECT/CT imaging for 30 to 45 minutes is recommended 3 to 6 hours after tracer injection. However, many of the patients who receive this radiotracer are elderly and present with neurological symptoms, making it difficult for them to remain still in the supine position for an extended period. In recent years, AI-assisted low-dose and short-duration imaging techniques in CT and MRI have been reported to produce image quality comparable to, or even exceeding, that of standard imaging. Based on this background, we hypothesize that in brain SPECT imaging using 123I-ioflupane, it is possible to generate virtual standard-time images from short-time acquisition data using AI-based image reconstruction, thereby achieving image quality comparable to that of standard acquisition. This study aims to test and validate that hypothesis.
Management information
Registered date
| 2025 | Year | 07 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066547
