UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000017013
Receipt No. R000019731
Scientific Title Utility of low tube voltage and iterative reconstruction algorithm in hepatic dynamic contrast-enhanced CT
Date of disclosure of the study information 2015/04/03
Last modified on 2019/04/18 (Ver. 7)

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Basic information
Public title Utility of low tube voltage and iterative reconstruction algorithm in hepatic dynamic contrast-enhanced CT
Acronym Utility of low tube voltage and iterative reconstruction algorithm in hepatic dynamic contrast-enhanced CT
Scientific Title Utility of low tube voltage and iterative reconstruction algorithm in hepatic dynamic contrast-enhanced CT
Scientific Title:Acronym Utility of low tube voltage and iterative reconstruction algorithm in hepatic dynamic contrast-enhanced CT
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the utility of a newly developed scan protocol of hepatic dynamic contrast-enhanced CT using low tube voltage and iterative reconstruction algorithm
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic performance of CT in detecting hepatocellular carcinomas
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Conventional scan protocol
Interventions/Control_2 Scan protocol with low tube voltage, reduced-dose of contrast material and iterative reconstruction algorithm
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 Patients with known or suspected liver tumor who are scheduled to undergo hepatic dynamic contrast-enhanced CT
Key exclusion criteria (1) patients who participated in this study in the past
(2) patients with a contraindication for the use of contrast material
(3) informed consent cannot be obtained
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name Yoshifumi
Middle name
Last name Narumi
Organization Osaka Medical College
Division name Department of Radiology
Zip code 569-8686
Address 2-7, Daigakumachi, Takatsuki
TEL 072-683-1221
Email narumi@poh.osaka-med.ac.jp

Public contact
1st name of contact person
1st name Atsushi
Middle name
Last name Nakamoto
Organization Osaka Medical College
Division name Department of Radiology
Zip code 569-8686
Address 2-7, Daigakumachi, Takatsuki
TEL 072-683-1221
Homepage URL
Email rad117@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Toshiba Medical Systems Corporation
Eisai Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka Medical College
Address 2-7, Daigakumachi, Takatsuki
Tel 072-683-1221
Email rad117@osaka-med.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
2015 Year 04 Month 03 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 89
Results 
Low tube voltage CT with AIDR 3D yielded a reduction in radiation dose and in
the amount of contrast material while maintaining diagnostic performance.
Results date posted
2019 Year 04 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 08 Month 24 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 04 Month 03 Day
Date of IRB
2015 Year 01 Month 05 Day
Anticipated trial start date
2015 Year 05 Month 18 Day
Last follow-up date
2018 Year 12 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
2015 Year 04 Month 01 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019731