UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024997
Receipt number R000028754
Scientific Title a feasibility study of partial resection of non-palpable breast cancer with calcification by Ultra breast marker.
Date of disclosure of the study information 2016/12/01
Last modified on 2018/11/28 10:10:13

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Basic information

Public title

a feasibility study of partial resection of non-palpable breast cancer with calcification by Ultra breast marker.

Acronym

Ultra breast marker feasibility study

Scientific Title

a feasibility study of partial resection of non-palpable breast cancer with calcification by Ultra breast marker.

Scientific Title:Acronym

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

1st name
Middle name
Last name Madoka Iwase

Organization

Aichi Cancer Center Hospital

Division name

Breast Oncology

Zip code


Address

1-1 kanokoden chikusa nagoya

TEL

0527626111

Email

miwase@aichi-cc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Madoka Iwase

Organization

Aichi Cancer Center Hospital

Division name

Breast Oncology

Zip code


Address

1-1 kanokoden chikusa nagoya

TEL

0527626111

Homepage URL


Email

miwase@aichi-cc.jp


Sponsor or person

Institute

Aichi cancer center

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


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

2016 Year 11 Month 20 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028754


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name