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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039241
Receipt No. 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

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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
Email 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
Email yukon@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043884

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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