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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024761
Receipt No. R000028358
Scientific Title Comparison of Superb Microvascular Imaging(SMI) and Contrast SMI for detection of angiogenesis in Thyroid tumor
Date of disclosure of the study information 2016/12/01
Last modified on 2019/03/15

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Basic information
Public title Comparison of Superb Microvascular Imaging(SMI) and Contrast SMI for detection of angiogenesis in Thyroid tumor
Acronym Comparison of Superb Microvascular Imaging(SMI) and Contrast SMI for detection of angiogenesis in Thyroid tumor
Scientific Title Comparison of Superb Microvascular Imaging(SMI) and Contrast SMI for detection of angiogenesis in Thyroid tumor
Scientific Title:Acronym Comparison of Superb Microvascular Imaging(SMI) and Contrast SMI for detection of angiogenesis in Thyroid tumor
Region
Japan

Condition
Condition Thyroid tumor
Classification by specialty
Endocrine surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical usefullness of SMI and contrast SMI for Thyroid tumor of differential diagnosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitibity, Specificity


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 Thyroid tumor group
US examinations were performed with a
diagnostic ultrasound system (Aplio-500;
Toshiba, Tokyo, Japan)
Sonazoid was injected intravenously
(bolus, 0.015 mL/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 1)Patients planned examination of ultrasound for diagnosis of Thyroid tumor
2) patients who consented to participate in this study
Key exclusion criteria 1) history of allergy to Sonazoid
2) history of allergy to eggs or egg products
3)Right to left shunts in heart or lung
4)Severe heart diseases
5)Severe lung diseases
6)Patients who plan to undergo digestive tract examination on the same day of contrast-enhanced ultrasonography
7)Pregnancy and possibility of the pregnancy or patients under the nursing
8)Not eligible for this study judged by doctors
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Nakashima
Organization Kawasaki Medical School
Division name Depertment of General Surgery
Zip code
Address 2-1-80 Nakasange, Kita-ku, Okayama 700-8505, Japan
TEL 086-225-2111
Email urbandoc@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Nakashima
Organization Kawasaki Medical School
Division name Depertment of General Surgery
Zip code
Address 2-1-80 Nakasange, Kita-ku, Okayama 700-8505, Japan
TEL 086-225-2111
Homepage URL
Email urbandoc@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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
2016 Year 12 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
2016 Year 11 Month 01 Day
Date of IRB
2017 Year 06 Month 12 Day
Anticipated trial start date
2017 Year 06 Month 12 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 08 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028358

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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