UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019889 |
|---|---|
| Receipt number | R000022977 |
| Scientific Title | Analysis of time-intensity Curves for the hepatic phases in Contrast Enhanced uLtrasonography with Perflubutane |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2017/05/03 18:12:58 |
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Basic information
Public title
Analysis of time-intensity Curves for the hepatic phases in Contrast Enhanced uLtrasonography with Perflubutane
Acronym
ACCEL-P
Scientific Title
Analysis of time-intensity Curves for the hepatic phases in Contrast Enhanced uLtrasonography with Perflubutane
Scientific Title:Acronym
ACCEL-P
Region
| Japan |
Condition
Condition
Healty people
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a contrast agent injection device SmartShot (Nemotokyorindo) to quantitatively set the dose rate of perufurubutan, the contrast effect appearing in artery and portal vein and analysed with time intensity curve. We try measuring the time for each phase of the contrast enhanced ultrasound, that is the definition of the arterial, portal venous, equilibrium phase .
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Artery phase and portal venous phase in CEUS.
Key secondary outcomes
Adverse effect and complication
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
After perfurlbutan 0.5ml was injected into the route of administration , and saline 10ml at a rate 3.0ml / sec using SmartShot.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The person can be the recognition of the abdominal aorta and portal vein in the abdominal ultrasonography .
Key exclusion criteria
The person allergic to perfulbutane.
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shintaro MIKAMI |
Organization
National Center for Global health and Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan (zip code: 162-8655)
TEL
03-3202-7181
me_car_3@mail.goo.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro MIKAMI |
Organization
National Center for Global health and Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan (zip code: 162-8655)
TEL
03-3202-7181
Homepage URL
me_car_3@mail.goo.ne.jp
Sponsor or person
Institute
Gastroenterology and Hepatology, National Center for Global health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
国立国際医療研究センター病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | 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
| 2015 | Year | 11 | Month | 21 | Day |
Last modified on
| 2017 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022977
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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