UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024761 |
|---|---|
| Receipt number | 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 15:06:38 |
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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
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
urbandoc@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028358
