UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011729 |
|---|---|
| Receipt number | R000013714 |
| Scientific Title | Usefulness of Cotrast-enhanced Ultrasonography with sonazoid for Head and Neck Lesion |
| Date of disclosure of the study information | 2013/09/13 |
| Last modified on | 2013/09/12 14:15:22 |
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Basic information
Public title
Usefulness of Cotrast-enhanced Ultrasonography with sonazoid for Head and Neck Lesion
Acronym
Usefulness of Cotrast-enhanced Ultrasonography with sonazoid for Head and Neck Lesion
Scientific Title
Usefulness of Cotrast-enhanced Ultrasonography with sonazoid for Head and Neck Lesion
Scientific Title:Acronym
Usefulness of Cotrast-enhanced Ultrasonography with sonazoid for Head and Neck Lesion
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess usefulness of contrast enhanced ultrasonography for identification of sentinel lymph node in patient with head and neck cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ultrasonographic findings of sentinel lymphography
Key secondary outcomes
Base
Study type
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
injection of contrast enhanced material for ultrasonography into the lesion of the patients
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
Untreated patients with head and neck cancer
patients who is over 20 years old and is scheduled surgery for head and neck cancer
Key exclusion criteria
patient with allergy to contrast enhanced material for ultrasonography
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iida Etsushi |
Organization
Yamaguchi University Hospital
Division name
Radiology
Zip code
Address
1-1-1 Minamikogushi Ube Yamaguchi
TEL
0836-22-2283
iida2283@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iida Etsushi |
Organization
Yamaguchi University Hospital
Division name
Radiology
Zip code
Address
1-1-1 Minamikogushi Ube Yamaguchi
TEL
0836-22-2283
Homepage URL
iida2283@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
Institute
Department
Personal name
Funding Source
Organization
department of radiology, school of medicin, Yamaguchi 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
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
| 2013 | Year | 09 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | 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
| 2013 | Year | 09 | Month | 12 | Day |
Last modified on
| 2013 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013714
