UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033424 |
|---|---|
| Receipt number | R000038110 |
| Scientific Title | Optimized contrast-enhanced hepatic CT by using dual-energy system |
| Date of disclosure of the study information | 2018/07/18 |
| Last modified on | 2018/07/18 00:16:22 |
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Basic information
Public title
Optimized contrast-enhanced hepatic CT by using dual-energy system
Acronym
Optimized contrast-enhanced hepatic CT by using dual-energy system
Scientific Title
Optimized contrast-enhanced hepatic CT by using dual-energy system
Scientific Title:Acronym
Optimized contrast-enhanced hepatic CT by using dual-energy system
Region
| Japan |
Condition
Condition
Hepatic disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To optimize iodine and radiation doses of dynamic contrast-enhanced hepatic CT scans.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Enhancement of the aorta
Key secondary outcomes
Enhancement of the portal vein and the liver prenchyma
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Reduced iodine dose
Interventions/Control_2
Standard iodine dose
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) Cases suspected hepatic disease who require dynamic contrast-enhanced hepatic CT
2) Cases underwent CT equipped with fast-kV switching dual-energy system
3) Cases with informed consent
Key exclusion criteria
1) Inadequate image quality due to patient factor or failure of equipment
2) Cases with multiple cysts or malignant tumors in the liver
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamichi Murakami |
Organization
Kindai University Faculty of Medicine
Division name
The Department of Radiology
Zip code
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511 Japan
TEL
072-366-0221
murakami@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Hyodo |
Organization
Kindai University Faculty of Medicine
Division name
The Department of Radiology
Zip code
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511 Japan
TEL
072-366-0221
Homepage URL
thyodo@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
This work was supported by JSPS KAKENHI Grant Number 24791346
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
近畿大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Main results already published
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 18 | Day |
Last modified on
| 2018 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038110
| 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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