UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051408 |
|---|---|
| Receipt number | R000058648 |
| Scientific Title | Real-life assessment of CEUS LI-RADS using Sonazoid in focal liver lesions in cirrhotic patients: a prospective multicenter study |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2024/06/21 12:28:57 |
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Basic information
Public title
Real-life assessment of CEUS LI-RADS using Sonazoid in focal liver lesions in cirrhotic patients: a prospective multicenter study
Acronym
Real-life assessment of CEUS LI-RADS using Sonazoid in focal liver lesions in cirrhotic patients: a prospective multicenter study
Scientific Title
Real-life assessment of CEUS LI-RADS using Sonazoid in focal liver lesions in cirrhotic patients: a prospective multicenter study
Scientific Title:Acronym
Real-life assessment of CEUS LI-RADS using Sonazoid in focal liver lesions in cirrhotic patients: a prospective multicenter study
Region
| Japan |
Condition
Condition
Focal liver lesions in patients with hepatitis B or hepatic cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the feasibility and diagnostic performance of original CEUS LI-RADS using Sonzoid for focal liver lesions including hepatocellular carcinoma
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of original CEUS LI-RADS using Sonazoid for focal liver lesions including hepatocellular carcinoma
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Focal liver lesions in patients with hepatitis B or hepatic cirrhosis
Patients received CEUS exmamination
Key exclusion criteria
Patients who has the history of egg allergy
Patients who has the history of Sonazoid allergy
Patients aged less than 18 year old
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Kudo |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2 Ohno-higashi Osaka-sayama, Osaka, Japan
TEL
072-366-0221
m-kudo@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Minami |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2 Ohno-higashi Osaka-sayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
minkun@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
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
Kindai Hospital Global Research Alliance Center
Address
377-2 Ohno-higashi Osaka-sayama, Osaka, Japan
Tel
072-366-0221
zizen@med.kindai.ac.jp
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
| 2023 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.med.kindai.ac.jp/shoukaki/research/data.html
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The basic information and medical data were prospectively collected from electronic health records for an observational clinical study
Management information
Registered date
| 2023 | Year | 06 | Month | 21 | Day |
Last modified on
| 2024 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058648
