UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000012547
Receipt number	R000014036
Scientific Title	Efficacy and safety of MRI guided vacuum assisted biopsy for MRI only visible lesion
Date of disclosure of the study information	2013/12/12
Last modified on	2020/01/30 19:22:38

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Basic information

Public title

Efficacy and safety of MRI guided vacuum assisted biopsy for MRI only visible lesion

Acronym

Efficacy and safety of MRI guided vacuum assisted biopsy

Scientific Title

Efficacy and safety of MRI guided vacuum assisted biopsy for MRI only visible lesion

Scientific Title:Acronym

Efficacy and safety of MRI guided vacuum assisted biopsy

Region

Japan

Condition

MRI only visible lesion

Classification by specialty

Breast surgery Radiology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To evaluate the efficacy and safety of MRI guided vacuum assisted biopsy for MRI only visible breast lesion

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Detection rate of breast cancer.

Key secondary outcomes

Hazardous phenomenon
Negative productive value
success rate of procedure
Pathological type

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

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

All patients are performed MRI guided vacuum assisted biopsy for MRI only visible breast lesion.
After the patient receives skin anesthesia, the needle path is cut by a precutter according to these coordinates. After the patient receives additional deep local anesthesia, VAB is performed outside the magnet, and specimens are acquired. After VAB is finished, the breast is reimaged before and after another contrast injection to check whether the intervention was successful.

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

20 years-old <=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1) 1:malignancy is highly suspected lesion (over category 4 BIRADS-MRI)
among MRI only visible lesions.
2:Biopsy is highly recommended lesion (over category 3 BIRADS-MRI)among MRI only visible lesions of which those have BRCA1 /2 mutation
2) Over twenty yeares-old.
3) Performance status is 0 to2.
4) An informed conscent was obtained from all patients after they had been provided with a detailed explanation about the procedure.

Key exclusion criteria

1)History of allergy for contrast medium (Gd-DTPA)
2) The lesion is too close to perform the procedure.
3) Serious heart disease or arrithmia.
4) Serious liver dysfunction
5) Serious renal dysfunction
6) During anti-coagulation therapy
7) MRI examination is impossible (ex. Installation of pacemaker, claustrophobia)
8) During or possible of pregnancy
9) Staff decides inadequate case for current study

Target sample size

Research contact person

Name of lead principal investigator

1st name Morihito

Middle name

Last name Okada

Organization

Hiroshima University Hospital

Division name

Breast Surgery

Zip code

734-8551

Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5869

Email

morihito@hiroshima-u.ac.jp

Public contact

Name of contact person

1st name Keiko

Middle name

Last name Kajitani

Organization

Hiroshima University Hospital

Division name

Breast Surgery

Zip code

734-8551

Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5869

Homepage URL

Email

kajitanikeiko0226@yahoo.co.jp

Sponsor or person

Institute

Hiroshima University Hospital

Institute

Department

Personal name

Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Ethical Committee for Clinical Research of Hiroshima University

Address

1-2-3 Kasumi, Minami-ku, Hiroshima

Tel

082-257-5907

Email

gaku-hiroshimajimu@office.hiroshima-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

広島大学病院（広島県）

Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 12 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

Terminated

Date of protocol fixation

2013 Year 10 Month 10 Day

Date of IRB

2013 Year 12 Month 04 Day

Anticipated trial start date

2013 Year 12 Month 05 Day

Last follow-up date

2020 Year 05 Month 30 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2013 Year 12 Month 11 Day

Last modified on

2020 Year 01 Month 30 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014036

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name