UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005537 |
|---|---|
| Receipt number | R000006569 |
| Scientific Title | Utility of contrast-enhanced intraoperative ultrasound using Sonazoid in patients undergoing surgery for liver metastasis from colorectal carcinoma - comparison with Gd-EOB-DTPA-MRI, contrast enhanced MDCT, and extracorporeal ultrasound- |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2012/11/01 13:18:47 |
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Basic information
Public title
Utility of contrast-enhanced intraoperative ultrasound using Sonazoid in patients undergoing surgery for liver metastasis from colorectal carcinoma - comparison with Gd-EOB-DTPA-MRI, contrast enhanced MDCT, and extracorporeal ultrasound-
Acronym
Contrast-enhanced intraoperative ultrasound using Sonazoid in patients with liver metastasis from colorectal carcinoma
Scientific Title
Utility of contrast-enhanced intraoperative ultrasound using Sonazoid in patients undergoing surgery for liver metastasis from colorectal carcinoma - comparison with Gd-EOB-DTPA-MRI, contrast enhanced MDCT, and extracorporeal ultrasound-
Scientific Title:Acronym
Contrast-enhanced intraoperative ultrasound using Sonazoid in patients with liver metastasis from colorectal carcinoma
Region
| Japan |
Condition
Condition
Liver metastasis from colorectal carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic ability of liver metastasis from colorectal carcinoma among contrast-enhanced intraoperative ultrasound, Gd-EOB-DTPA-MRI, contrast-enhanced MDCT, extracorporeal contrast-enhanced ultrasoud and intraoperative ultrasoud
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
*Frequency that contrast-enhanced intraoperative ultrasound alone finds new liver metastases that have not been detected by preoperative imaging studies or intraoperative ultrasound
Key secondary outcomes
*Diagnostic abilities for liver metastasis of contrast-enhanced intraoperative ultrasound, Gd-EOB-DTPA-MRI, contrast-enhanced MDCT, extracorporeal contrast-enhanced ultrasoud and intraoperative ultrasoud
*Diagnostic ability of contrast-enhanced intraoperative ultrasound among new focal liver lesions that are found by intraoprative ultrasound
*Frequency that the planned surgical precedure is altered through contrast-enhanced intraoperative ultrasound
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
| Maneuver |
Interventions/Control_1
Contrast-enhanced intraoperative ultrasound
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
* Planned to undergo hepatic resection for liver metastasis from colorectal carcinoma
* Age 20 years or more
* Written informed consent is gained
Key exclusion criteria
* History of allergy against Sonazoid or an egg
* Contrast-enhanced MDCT or Gd-EOB-DTPA-MRI is impossible based on history of allergy or renal dysfunction
* 10 or more liver metastases
* Arterio-venous shunt in heart or lung
* Severe heart disease
* Severe pulmonary disease
* Pregnant patients
* Nursing mothers
* Attending physician or the operator consider the study hazardous
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Arita |
Organization
Cancer institute hospital
Division name
Digestive surgery division
Zip code
Address
3-8-31, Ariake, Kouto-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Cancer institute hospital
Division name
Digestive surgery division
Zip code
Address
TEL
Homepage URL
jarita-tky@umin.ac.jp
Sponsor or person
Institute
Cancer institute 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
がん研有明病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | 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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2012 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 01 | Day |
Last modified on
| 2012 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006569
