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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009225
Receipt No. R000010836
Scientific Title Low dose abdominal CT using iterative reconstruction technique
Date of disclosure of the study information 2012/11/01
Last modified on 2015/10/31

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Basic information
Public title Low dose abdominal CT using iterative
reconstruction technique
Acronym Low dose abdominal CT
Scientific Title Low dose abdominal CT using iterative
reconstruction technique
Scientific Title:Acronym Low dose abdominal CT
Region
Japan

Condition
Condition Abdominal diseases
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To invastigate the effect of low dose scan at
abdominal CT using a iterative reconstruction
technique on image quality.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Image quality of abdominal CT
Key secondary outcomes Diagnostic performance of abdominal CT

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 1/2 Radiation dose
Interventions/Control_2 1/4 Radiation dose
Interventions/Control_3 1/8 Radiation dose
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who intended to abdominal CT
examinations for the diagnosis of abdominal diseases
Key exclusion criteria 1) Patients who have been already enrolled in this study
2) Patients who can not hold their breaths
3) Patients who do not give consents
Target sample size 90

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tonsok Kim
Organization Osaka University Graduate School of
Medicine
Division name Department of Radiology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of
Division name Department of Radiology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka
TEL
Homepage URL
Email

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Osaka University
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
Address
Tel
Email

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
2012 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 31 Day
Last modified on
2015 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010836

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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