臨床研究等提出・公開システム

Date of registration	Sept. 15, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220863

Scientific Title	DD-723 Phase II clinical trial - Dose-response study in patients with breast tumor -
Public Title	DD-723 Phase II 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		75
Study Type		Interventional
Study Design	Study Design	Multicenter, randomized, single-blind controlled trial
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	- Patients with focal breast tumor - Patients scheduled to undergo pathological examination - Patients aged between 20 and 80 years 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 that are considered to influence efficacy and safety assessment for this drug - Patients who are pregnant, possibly, pregnant, or lactating
	Minimum Age	20age old over
	Maximum Age	80age old under
	Gender	Both
Health Condition or Problem Studied		Patients 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 : A single dose of 0.024 uL MB/kg, 0.12 uL MB/kg, or 0.36 uL MB/kg delivered via a forearm vein
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Effectiveness of contrast effect
Secondary Outcome		Right diagnosis between benign and malignant tumor, assessment of tumor extent

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor	None

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-090894
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
8	Dec. 17, 2018	(this page)	Changes
7	Sept. 24, 2014	Detail	Changes
6	Sept. 24, 2014	Detail	Changes
5	Jan. 27, 2011	Detail	Changes
4	Jan. 27, 2011	Detail	Changes
3	May. 12, 2010	Detail	Changes
2	May. 12, 2010	Detail	Changes
1	Sept. 15, 2009	Detail

List of change history