UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of time-intensity Curves for the hepatic phases in Contrast Enhanced uLtrasonography with Perflubutane
Title of the study (Brief title)	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	Shintaro MIKAMI
Organization	National Center for Global health and Medicine
Division name	Gastroenterology and Hepatology
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	Shintaro MIKAMI
Organization	National Center for Global health and Medicine
Division name	Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 11 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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