UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023626 |
|---|---|
| Receipt number | R000027210 |
| Scientific Title | Assesssment of liver function by using dual-energy CT |
| Date of disclosure of the study information | 2016/08/15 |
| Last modified on | 2016/08/14 20:59:26 |
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Basic information
Public title
Assesssment of liver function by using dual-energy CT
Acronym
Assesssment of liver function by using dual-energy CT
Scientific Title
Assesssment of liver function by using dual-energy CT
Scientific Title:Acronym
Assesssment of liver function by using dual-energy CT
Region
| Japan |
Condition
Condition
Chronic liver disease
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of material decomposition image generated from dual-energy CT data in patients with chronic liver disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison between fat content measured using spectral CT imaging and biopsy findings
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
dual-energy data acquisition in CT exam
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
Patients who will undergo dynamic contrast-enhanced CT of the liver due to suspected or known liver disease
Key exclusion criteria
Patients who don't agree to participate in this study
Patients with possible pregnancy
Patients with infectious disease
Patients with allergy to iodinated contrast media
Patients with severe complication
Patients ineligible for CT due to other reason
Target sample size
40
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(3133)
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(3133)
Homepage URL
hyoudou@radiol.med.kindai.ac.jp
Sponsor or person
Institute
The Department of Radiology,
Kindai University Faculty of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511,
Japan
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2016 | Year | 08 | Month | 15 | 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
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 | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 19 | 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
| 2016 | Year | 08 | Month | 14 | Day |
Last modified on
| 2016 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027210
