UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020395 |
|---|---|
| Receipt number | R000023556 |
| Scientific Title | A study to evaluate the usefulness of contrast medium 'Sonazoid; Perflubutane' in EUS diagnosis for pancreaticobiliary tumors. |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2019/01/10 17:36:09 |
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Basic information
Public title
A study to evaluate the usefulness of contrast medium 'Sonazoid; Perflubutane' in EUS diagnosis for pancreaticobiliary tumors.
Acronym
Usefulness of contrast medium Sonazoid in EUS diagnosis for pancreaticobiliary tumors.
Scientific Title
A study to evaluate the usefulness of contrast medium 'Sonazoid; Perflubutane' in EUS diagnosis for pancreaticobiliary tumors.
Scientific Title:Acronym
Usefulness of contrast medium Sonazoid in EUS diagnosis for pancreaticobiliary tumors.
Region
| Japan |
Condition
Condition
pancreaticobiliary neoplastic lesions that require EUS
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of contrast medium 'Sonazoid; Perflubutane' in EUS diagnosis for pancreaticobiliary tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
final diagnostic performance,
pathological diagnostic accuracy
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Sonazoid;Perflubutane suspension
0.015ml/kg
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
Patients with pancreaticobiliary neoplastic lesions that require EUS.
Key exclusion criteria
Cases under 20 years old
Cases without written informed consent
Cases with allergy for Sonazoid; Perflubutane
Cases with possibility of pregnant
Cases considered ineligible for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Takaoka |
Organization
Kansai Medical University
Hirakata Hospital
Division name
Div. of Gastroenterology and Hepatology, Dept. of Internal Medicine.
Zip code
Address
5-1, Shinmachi 2-chome, Hirakata city, Osaka pref 573-1191, Japan
TEL
072-804-0101
takaokam@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Takaoka |
Organization
Kansai Medical University
Division name
Div. of Gastroenterology and Hepatology, Dept. of Internal Medicine.
Zip code
Address
5-1, Shinmachi 2-chome, Hirakata city, Osaka pref 573-1191, Japan
TEL
072-804-0101
Homepage URL
kenkyu@hirakata.kmu.ac.jp
Sponsor or person
Institute
Div. of Gastroenterology and Hepatology, Dept. of Internal Medicine. Kansai Medical University Hirakata 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
None
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
| 2016 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 29 | Day |
Last modified on
| 2019 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023556
