UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003046 |
|---|---|
| Receipt number | R000003695 |
| Scientific Title | Utility of contrast enhanced intraoperative ultrasound using Sonazoid for patients with hepatocellular carcinoma |
| Date of disclosure of the study information | 2010/01/16 |
| Last modified on | 2011/02/05 13:29:53 |
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Basic information
Public title
Utility of contrast enhanced intraoperative ultrasound using Sonazoid for patients with hepatocellular carcinoma
Acronym
Contrast enhanced intraoperative ultrasound using Sonazoid for hepatocellular carcinoma
Scientific Title
Utility of contrast enhanced intraoperative ultrasound using Sonazoid for patients with hepatocellular carcinoma
Scientific Title:Acronym
Contrast enhanced intraoperative ultrasound using Sonazoid for hepatocellular carcinoma
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the ability of contrast enhanced intraoperative ultrasoud using Sonazoid to detect, diagnose, and resect new hepatocellular carcinomas which have not been diagnosed during the preoperative imaging study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Diagnostic ability to differentiate new lesions detected during conventional fundamental intraoperative ultrasound.
2. Frequency to find new hepatocellular carcinoma solely by contrast enhanced intraoperative ultrasound.
Key secondary outcomes
Safety of contrast enhanced intraoperative ultrasound using Sonazoid.
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 | Device,equipment |
Interventions/Control_1
Contrast enhanced intraoperative ultrasound using 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgery for hepatocellular carcinoma
Key exclusion criteria
1. Cardiac failure
2. Allergy against egg
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
University of Tokyo Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division and Artificial Organ and Transplantation Division
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
+81-3-5800-8655
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tokyo Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division and Artificial Organ and Transplantation Division
Zip code
Address
7-3-1, Bunkyo-Ku, Hongo, Tokyo, 113-8655, Japan
TEL
Homepage URL
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division and Artificial Organ and Transplantation Division, University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 07 | Month | 07 | 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
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 16 | Day |
Last modified on
| 2011 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003695
