UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015389
Receipt number R000017753
Scientific Title Potential detectability of blood flow in hepatocellular carcinoma using contrast-enhanced ultrasonography with Sonazoid (Comparison with transvenous contrast-enhanced computed tomography or computed tomography with angiography)
Date of disclosure of the study information 2014/10/10
Last modified on 2015/10/26 15:54:30

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Basic information

Public title

Potential detectability of blood flow in hepatocellular carcinoma using contrast-enhanced ultrasonography with Sonazoid (Comparison with transvenous contrast-enhanced computed tomography or computed tomography with angiography)

Acronym

Potential detectability of tumor blood flow using contrast-enhanced ultrasonography

Scientific Title

Potential detectability of blood flow in hepatocellular carcinoma using contrast-enhanced ultrasonography with Sonazoid (Comparison with transvenous contrast-enhanced computed tomography or computed tomography with angiography)

Scientific Title:Acronym

Potential detectability of tumor blood flow using contrast-enhanced ultrasonography

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of the findings of tumor blood flow using contrast-enhanced ultrasonography by comparison with transvenous contrast-enhanced computed tomography or computed tomography with angiography

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Potential detectability of tumor blood flow using contrast-enhanced ultrasonography, intravenous contrast-enhaced computed tomography, and computed tomography with angiography

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

Medicine

Interventions/Control_1

Microbubble contrast agents; Sonazoid

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Presence of suspected hepatocellular carcinomas of 30 mm in size or less by ultrasonography
2. Patients who were able to conduct the examinations within two weeks; intravenous contrast-enhanced computed tomography, computed tomography with angiography, and contrast-enhanced ultrasonography
3. Having received adequate explanation of the contents of the trial and given their written consent

Key exclusion criteria

1. Egg allergy
2. Severe lung disease
3. Severe heart disease
4. Hepatocellular carcinomas are not supplied by hepatic artery.
5. Tumors are diagnosed not to be hepatocellular carcinomas.
6. Determined to be ineligible by the physician in charge for any other reason.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitoshi Maruyama

Organization

Chiba University Graduate School of Medicine

Division name

Department of Gastroenterology and Nephrology

Zip code


Address

1-8-1, Inohana, Chuou-ku, Chiba, Japan

TEL

043-226-2083

Email

maru-cib@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitoshi Maruyama

Organization

Chiba University Graduate School of Medicine

Division name

Department of Gastroenterology and Nephrology

Zip code


Address

1-8-1, Inohana, Chuou-ku, Chiba, Japan

TEL

043-226-2083

Homepage URL


Email

maru-cib@umin.ac.jp


Sponsor or person

Institute

Chiba University Graduate School of Medicine, Department of Gastroenterology and Nephrology

Institute

Department

Personal name



Funding Source

Organization

Chiba University Graduate School of Medicine, Department of Gastroenterology and Nephrology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 10 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

2008 Year 06 Month 18 Day

Date of IRB


Anticipated trial start date

2008 Year 07 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

2014 Year 10 Month 09 Day

Last modified on

2015 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017753


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name