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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011731
Receipt No. R000013718
Scientific Title Usefulness of contrast-enhanced ultrasonography with Sonazoid for Head and Nedk Lesion
Date of disclosure of the study information 2013/09/13
Last modified on 2013/09/12

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Basic information
Public title Usefulness of contrast-enhanced ultrasonography with Sonazoid for Head and Nedk Lesion
Acronym Usefulness of contrast-enhanced ultrasonography with Sonazoid for Head and Nedk Lesion
Scientific Title Usefulness of contrast-enhanced ultrasonography with Sonazoid for Head and Nedk Lesion
Scientific Title:Acronym Usefulness of contrast-enhanced ultrasonography with Sonazoid for Head and Nedk Lesion
Region
Japan

Condition
Condition Head and neck tumor
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 diagnosis of head and neck lesion
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes contrast enhanced ultrasonographic findings of head and neck lesions
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 Prevention
Type of intervention
Medicine
Interventions/Control_1 administration of contrast enhanced material for ultrasonography
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 head and neck tumor
patients who is scheduled histopathologic examination
Key exclusion criteria patients with allergy to contrast enhanced material
Target sample size 200

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 1-1-1Minamikogushi Ube Yamaguchi Japan
TEL 0836-22-2283
Email 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 1-1-1Minamikogushi Ube Yamaguchi Japan
TEL 0836-22-2283
Homepage URL
Email iida2283@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Hospital
Institute
Department

Funding Source
Organization Department of Radiology, school of medicine, 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
Email

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 Enrolling by invitation
Date of protocol fixation
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013718

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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