UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035663 |
|---|---|
| Receipt number | R000035042 |
| Scientific Title | Nationwide survey of radiation exposure on pediatric computed tomography in Japan (2018) |
| Date of disclosure of the study information | 2019/01/26 |
| Last modified on | 2024/03/22 07:48:47 |
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Basic information
Public title
Nationwide survey of radiation exposure on pediatric computed tomography in Japan (2018)
Acronym
Nationwide survey of pediatric CT exposure
Scientific Title
Nationwide survey of radiation exposure on pediatric computed tomography in Japan (2018)
Scientific Title:Acronym
Nationwide survey of pediatric CT exposure
Region
| Japan |
Condition
Condition
pediatric CT examinations
Enrollment criteria included pediatric patients underwent computed tomography examination.
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect the pediatric CT exposure data
Basic objectives2
Others
Basic objectives -Others
Revising the Japan diagnostic reference levels
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Volume computed tomography dose index (CTDIvol) and dose length product (DLP)
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
Pediatric patients who underwent computed tomography examinations.
Key exclusion criteria
Pediatric patients who underwent emergency CT on overtime, SPECT-CT and PET CT examinations.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Takei |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Radiological Technology, Faculty of Health Science and Technology
Zip code
7010193
Address
288, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
ytakei@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Takei |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Radiological Technology, Faculty of Health Science and Technology
Zip code
7010193
Address
288, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
ytakei@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Radiological Technology
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
Institutional Review Board of Kawasaki University of Medical Welfare
Address
288, Matsushima, Kurashiki, Okayama
Tel
0864621111
office@mw.kawasaki-m.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
| 2019 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jjrt/78/4/78_2022-1181/_article/-char/ja/
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jjrt/78/4/78_2022-1181/_article/-char/ja/
Number of participants that the trial has enrolled
43
Results
In all, 43facilities (11%) responded to our survey. multi detector-row CT (MDCT) systems were available in all surveyed facilities.
More than 98% of the MDCT systems had more than 64 detector rows. The CTDIvol of all CT protocols was lower than the NDRL due to the progress of updating to MDCTs with radiation exposure reduction functions such as an iterative reconstruction, but the DLP of head and abdominal CT protocols of some age group were higher than NDRL.
Results date posted
| 2024 | Year | 03 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 03 | Day |
Baseline Characteristics
A questionnaire was sent to 409 facilities where the members of the Japanese Society of Radiological Technology and the Japanese Society of Pediatric Radiology are enrolled
Participant flow
Facilities that were willing to cooperate in the survey were asked to download the necessary documents from Google Drive and provide data on 50 consecutive pediatric CT examinations performed between the end of July 2017 and the end of February 2020. We requested data on 50 consecutive cases in order to reduce the burden of data extraction and tabulation at the collaborating institutions. We excluded CT examinations performed after-hours, such as during the night or on holidays, and CT examinations for treatment planning from the survey.
Adverse events
no adverse events.
Outcome measures
the imaging conditions, CTDIvol, and DLP of the pediatric head, chest, and abdominal CT examinations.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Age,Height,weight, examination region, CT scan protocols, Name of CT equipments.
Management information
Registered date
| 2019 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035042
