UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039241 |
|---|---|
| Receipt number | R000043884 |
| Scientific Title | Radiation dose reduction with deep learning reconstruction for abdominal CT in obese patients |
| Date of disclosure of the study information | 2020/01/23 |
| Last modified on | 2020/12/10 08:59:21 |
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Basic information
Public title
Radiation dose reduction with a new CT image reconstruction for abdominal CT in obese patients
Acronym
Radiation dose reduction with a new CT image reconstruction for abdominal CT in obese patients
Scientific Title
Radiation dose reduction with deep learning reconstruction for abdominal CT in obese patients
Scientific Title:Acronym
Radiation dose reduction with deep learning reconstruction for abdominal CT in obese patients
Region
| Japan |
Condition
Condition
Obese patients who are scheduled to have hepatic dynamic CT for assessment of hepatic disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the radiation dose at hepatic dynamic CT can be reduced without degradation of image quality using deep learning reconstruction in obese patients
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To confirm that image noise of hepatic CT acquired at low radiation dose can be reduced with deep learning reconstruction to the same level as that acquired at routine radiation dose
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Scan hepatic dynamic CT at 70% radiation dose and reconstruct CT images with deep learning reconstruction (only one intervention for each patient).
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
1.Patients who are scheduled to have hepatic dynamic CT for assessment of hepatic disease
2.Patients with body mass index over 25
3.Patients who have consent to participate in this study
Key exclusion criteria
1.Patients with a history of severe side effects to CT contrast material
2.Patients with poor general condition
3.Patients with asthma
4.Patients with severe renal failure
(eGFR under 30ml/min/1.73mm2)
5.Pregnant or breastfeeding patients
6.Patients who are judged to be unsuitable for this study by researchers
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Awai |
Organization
Hiroshima University
Division name
Diagnostic Radiology
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
0822575257
awai@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Nakamura |
Organization
Hiroshima University
Division name
Diagnostic Radiology
Zip code
7348551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
0822575257
Homepage URL
yukon@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
0822575257
yukon@hiroshima-u.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
| 2020 | Year | 01 | Month | 23 | 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
10
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 | 11 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 01 | Month | 23 | Day |
Last modified on
| 2020 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043884
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
