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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013345
Receipt No. R000015484
Scientific Title The evaluation of the usefulness of Parametric Imaging of Contrast Enhanced Ultrasound for Breast Cancer.
Date of disclosure of the study information 2014/04/01
Last modified on 2016/04/04

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Basic information
Public title The evaluation of the usefulness of Parametric Imaging of Contrast Enhanced Ultrasound for Breast Cancer.
Acronym The evaluation of the usefulness of Parametric Imaging of Contrast Enhanced Ultrasound for Breast Cancer.
Scientific Title The evaluation of the usefulness of Parametric Imaging of Contrast Enhanced Ultrasound for Breast Cancer.
Scientific Title:Acronym The evaluation of the usefulness of Parametric Imaging of Contrast Enhanced Ultrasound for Breast Cancer.
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Currently, we are defining the area of extent of the breast cancer by Breast CEUS. On the still image, it is difficult to distinguish between the inflow vessel and the lesion in the breast duct. Usually we use dynamic image and accumulated captured image to distinguish them. If we use Parametric imaging, we would display colors which are corresponding to arrival time. It may increase the visibility, then make it easier than current way and improve the work flow.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Perform CEUS before surgery. Compare dynamic image to parametric image. Then evaluate which is easier to distinguish the area of extent of the breast cancer. Next, compare to accumulation image to parametric image. Then evaluate which is easier to distinguish the area of extent of the breast cancer.
Key secondary outcomes Compare parametric image to surgical specimen. Then evaluate the accuracy of the definition of the extent of the breast cancer.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 The subjects are patients aged 20 years or older with a breast mass detected by gray-scale ultrasound sonography. They are diagnosed malignant pathologically, and are scheduled operation. Written informed consent for this study is obtained from all patients before enrollment.
Key exclusion criteria Patients who have an allergy to eggs, severe cardiopulmonary disease, hypersensitivity to perfulbutane, and be pregnant or nursing are excluded. Patients who are judged inappropriate by principal investigator or co-investigators are also excluded.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ogawa Tomoko
Organization Mie University Hospital
Division name Department of breast surgery
Zip code
Address 2-174, Edobashi, Tsu city, Mie, 514-8507, Japan
TEL 059-231-5584
Email breastcenter@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nakamura Takashi
Organization Mie University Hospital
Division name Department of breast surgery
Zip code
Address 2-174, Edobashi, Tsu city, Mie, 514-8507, Japan
TEL 059-231-5584
Homepage URL
Email takashi-n@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Nara Medical University
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 三重大学医学部附属病院(三重県)、奈良県立医科大学(奈良県)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26801662
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
2013 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information prospective study

Management information
Registered date
2014 Year 03 Month 05 Day
Last modified on
2016 Year 04 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015484

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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