UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006226 |
|---|---|
| Receipt number | R000007373 |
| Scientific Title | Usefulness of the Kupffer phase study of contrast-enhanced ultrasound using Sonazoid for detection of hepatocellular carcinoma. |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2016/02/25 13:04:03 |
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Basic information
Public title
Usefulness of the Kupffer phase study of contrast-enhanced ultrasound using Sonazoid for detection of hepatocellular carcinoma.
Acronym
Kupffer phase study
Scientific Title
Usefulness of the Kupffer phase study of contrast-enhanced ultrasound using Sonazoid for detection of hepatocellular carcinoma.
Scientific Title:Acronym
Kupffer phase study
Region
| Japan |
Condition
Condition
Hepatitis patients due to alcoholic or virus with the platelet count is under 150,000 /ul
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prove the usefulness of Kupffer phase of contrast-enhance ultrasound for detection of hepatocellular carcinoma, it compares to conventional B-mode ultrasound for the patients with advanced hepatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of Hepatocellular carcinoma
Key secondary outcomes
Size of tumor
Numbers of tumor
Detection of focal liver lesion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Screening by Kupffer phase of contrast-enhanced ultrasound using Sonazoid.
Interventions/Control_2
Screening by conventional B-mode US.
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
1) Age over 20
2) Hepatitis patients with the platelet count is under 150,000 /ul
3) No history of HCC
4) Inpatient or outpatient
5) Patients who signed a written informed consent form
Key exclusion criteria
1) History of hypersensitivity to egg yolk
2) Pregnant or lactating women and women who may be pregnant
3) Severe liver dysfunction(AST, ALT,or BIL level >10ULN
4) Associated with HCC
5) Paients receiving interferon
6) Age under 20
7) Judged by investigator not to be appropriate for inclusion in this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu |
Organization
Osaka City University
Division name
Department of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abeno,Osaka
TEL
06-6645-3811
morikawa-h@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwai Shuji |
Organization
Osaka Socio-Medical Center Hospital
Division name
Department of Internal Medicine
Zip code
Address
1-3-44 Oginotyaya, Nishinari, Osaka
TEL
06-6649-0321
Homepage URL
osmc1970@eagle.ocn.ne.jp
Sponsor or person
Institute
Osaka Socio-Medical Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Socio-Medical Center Hospital
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
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
大阪社会医療センター
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | 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
| 2011 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
| 2011 | Year | 08 | Month | 24 | Day |
Last modified on
| 2016 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007373
