UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003139 |
|---|---|
| Receipt number | R000003803 |
| Scientific Title | Utility of contrast enhanced intraoperative ultrasound with Sonazoid for patients with liver tumors |
| Date of disclosure of the study information | 2010/02/04 |
| Last modified on | 2022/12/26 17:18:21 |
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Basic information
Public title
Utility of contrast enhanced intraoperative ultrasound with Sonazoid for patients with liver tumors
Acronym
Sonazoid IOUS for liver tumors
Scientific Title
Utility of contrast enhanced intraoperative ultrasound with Sonazoid for patients with liver tumors
Scientific Title:Acronym
Sonazoid IOUS for liver tumors
Region
| Japan |
Condition
Condition
metastatic liver tumors
primary hepatic tumors
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 liver tumors which have not been diagnosed during the preoperative imaging study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
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 liver tumors
Key exclusion criteria
1, Cardiac failure
2. Respiratory failure
3. Allergy for egg
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Takamoto |
Organization
Japanese Red Cross Medical Center
Division name
Hepato-biliary-pancreatic surgery
Zip code
Address
4-1-22 Hiroo Shibuya-ku Tokyo
TEL
03-3400-1311
takamoto@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Takamoto |
Organization
Japanese Red Cross Medical Center
Division name
Hepato-biliary-pancreatic surgery
Zip code
Address
4-1-22 Hiroo Shibuya-ku Tokyo
TEL
03-3400-1311
Homepage URL
takamoto@nifty.com
Sponsor or person
Institute
Japanese Red Cross Medical Center
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 04 | 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
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 04 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003803
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
