UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of the usefulness of Parametric Imaging of Contrast Enhanced Ultrasound for Breast Cancer.
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Ogawa Tomoko
Organization	Mie University Hospital
Division name	Department of breast surgery
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	Nakamura Takashi
Organization	Mie University Hospital
Division name	Department of breast surgery
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/26801662
Results
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://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000015484