臨床研究等提出・公開システム

Date of registration	Sept. 27, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221250

Scientific Title	DD-723 Phase III Clinical Trial - Confirmatory Study in Subjects with Breast Tumor -
Public Title	DD-723 Phase III Clinical Trial (Breast)

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/contact/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		120
Study Type		Interventional
Study Design	Study Design	Multicenter open-label study under central registration
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	- Subjects with focal breast tumors - Subjects scheduled to undergo pathological examination - Subjects aged >=20 years old at the time of informed consent
	Exclusion Criteria	- Items listed on the package insert (including absolute contraindications, careful administration, and precautions) to ensure safety - Items related to safety and ethics - Items related to surgery, procedures, and treatment influencing efficacy and safety assessment for DD-723 - Subjects who are pregnant, possibly pregnant, or lactating
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Subjects with breast tumor
Intervention(s)		investigational material(s) Generic name etc : DD-723 INN of investigational material : Perflubutane Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicines) Dosage and Administration for Investigational material : Single intravenous dose of 0.12microL MB/kg administered via the forearm
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Diagnostic accuracy rate of differential diagnosis Assessment by the blinded readers
Secondary Outcome		Differential diagnostic performance, assessment of tumor extent diagnosis, evaluation of contrast effect Assessment by the blinded readers

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-101287
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	Sept. 24, 2014	Detail	Changes
9	Sept. 24, 2014	Detail	Changes
8	Nov. 28, 2011	Detail	Changes
7	Nov. 28, 2011	Detail	Changes
6	July. 29, 2011	Detail	Changes
5	July. 29, 2011	Detail	Changes
4	Jan. 27, 2011	Detail	Changes
3	Jan. 27, 2011	Detail	Changes
2	Sept. 27, 2010	Detail	Changes
1	Sept. 27, 2010	Detail

List of change history