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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019889
Receipt No. 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

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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
Email 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
Email me_car_3@mail.goo.ne.jp

Sponsor
Institute Gastroenterology and Hepatology, National Center for Global health and Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022977

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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