UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	a feasibility study of partial resection of non-palpable breast cancer with calcification by Ultra breast marker.
Title of the study (Brief title)	Ultra breast marker feasibility study
Region	Japan

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

Objectives
Narrative objectives1	to verify the safety and accuracy of breast conserving surgery for non-palpable calcification breast cancer with Ultra breast marker
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	feasibility: to insert breast marker safety and accurately into the target site when inserting the Ultra breast marker
Key secondary outcomes	margin positive rate, boost radiation, additional resection, operation time, allergy

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Patients receive Ultra breast marker at the time of stereo-mammotome biopsy against non-palpable calcified lesions suspected of being breast cancer
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) The patient who undergoes ST-MMT in the Aichi Cancer Center Hospital for non-palpable calcified lesions(category 3 or more) suspected of breast cancer 2) The calcified lesions can't be identified by US. 3) ECOG performance status PS0 4) Patient age is 18 years or older 5) Platelet : 10000 and more PT-INR 1.5 or less 6)informed consent 7) Without platelet aggregation inhibitor, Anticoagulant 8) Patients have to receive detailed US
Key exclusion criteria	1) The lesion can be identified by the US. 2) Total Mastectomy is planned. 3) Informed consent is not obtained.
Target sample size	10

Research contact person
Name of lead principal investigator	Madoka Iwase
Organization	Aichi Cancer Center Hospital
Division name	Breast Oncology
Address	1-1 kanokoden chikusa nagoya
TEL	0527626111
Email	miwase@aichi-cc.jp

Public contact
Name of contact person	Madoka Iwase
Organization	Aichi Cancer Center Hospital
Division name	Breast Oncology
Address	1-1 kanokoden chikusa nagoya
TEL	0527626111
Homepage URL
Email	miwase@aichi-cc.jp

Sponsor
Institute	Aichi cancer center
Institute
Department

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

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 20 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2018 Year 11 Month 01 Day
Date of closure to data entry	2018 Year 11 Month 01 Day
Date trial data considered complete	2018 Year 11 Month 01 Day
Date analysis concluded	2018 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 25 Day
Last modified on	2018 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028754