UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011330 |
|---|---|
| Receipt number | R000013225 |
| Scientific Title | Non-invasive method for evaluating the development of interstitial structure and cancer malignancy using contrast-enhanced ultrasonography using Sonazoid |
| Date of disclosure of the study information | 2013/07/31 |
| Last modified on | 2021/08/06 15:40:27 |
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Basic information
Public title
Non-invasive method for evaluating the development of interstitial structure and cancer malignancy using contrast-enhanced ultrasonography using Sonazoid
Acronym
Non-invasive method for evaluating the development of interstitial structure and cancer malignancy using contrast-enhanced ultrasonography using Sonazoid
Scientific Title
Non-invasive method for evaluating the development of interstitial structure and cancer malignancy using contrast-enhanced ultrasonography using Sonazoid
Scientific Title:Acronym
Non-invasive method for evaluating the development of interstitial structure and cancer malignancy using contrast-enhanced ultrasonography using Sonazoid
Region
| Japan |
Condition
Condition
1. malignant tumor in the liver
2. chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a non-invasive method of evaluating interstitial structure and malignancy in the liver
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Effectiveness of Sonazoid contrast ultrasound in the diagnosis and grade definitive diagnosis of malignancy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
age; over 20 years
Gender: unquestioned
Patients with any of the following
1. And or, with malignant tumors, patients with malignant tumor is suspected
2. Chronic liver disease patients with malignant tumors
Key exclusion criteria
Patients with a history of hypersensitivity to drug test
Patients who are allergic to egg products or egg
Patient nursing and pregnancy
Patients attending physician has determined is inappropriate participation in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sawako Uchida |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3 , Asahimachi, Abeno-ku, Osaka 545-8585, Japan.
TEL
06-6645-3905
sawako@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sawako Uchida |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3 , Asahimachi, Abeno-ku, Osaka 545-8585, Japan.
TEL
06-6645-3905
Homepage URL
sawako@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Department of Hepatology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 31 | 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
| 2009 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2004 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2004 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2005 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2013 | Year | 07 | Month | 31 | Day |
Last modified on
| 2021 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013225
