UMIN-CTR Clinical Trial

Public title

MR-guided vacuum assisted biopsy for MRI-only visible lesion.

Acronym

Breast Interventional Radiology Using MRI in Mie (BIRUMM-01)

Scientific Title

MR-guided vacuum assisted biopsy for MRI-only visible lesion.

Scientific Title:Acronym

Breast Interventional Radiology Using MRI in Mie (BIRUMM-01)

Region

Japan

Condition

MRI-only visible lesion

Classification by specialty

Breast surgery

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

MR-guided vacuum-assisted breast biopsy for MRI-only visible lesion is established safety. And feasibility of its procedure is evaluated for correct diagnosis obtained pathologic specimen.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Detection rate of breast cancer.

Key secondary outcomes

Hazardous phenomenon, Negative productive value, success rate of procedure, Pathologic type of obtained specimen, Surgical method (case of malignancy)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

<Study term>1)Registration: from 11/01/2010 to 12/31/2012. 2)Follow-up: a year after registration. 3) Total: 3 years and 4 months. <Protocol>Target lesion is single every procedure. When multiple lesions are observed on one-side or both breast, target is decided by staff of current study. Both breast is not done every procedure. Each procedure is performed in a prone position in MR scanner (Signa, GE healthcare). The affected breast is stabilized with moderate compression from a lateral fenestrated grid. A peripheral oxygen-saturation is monitored on the patient's finger. A fiducial marker is placed around the expected site of the target lesion, and localizing sequences are acquired. Gd-DTPA 0.1 mmol/L per kg of body weight is administered rapidly through an existing peripheral IV catheter, and sagittal T1-weighted fast sequences are acquired. Images are reviewed by monitor, three dimensional measurement is determined by two technologists. The MRI table and patient are withdrawn from the magnet, and the location of the lesion is established on the grid. The skin is anesthetized, and a skin incision is made. The handheld vacuum assisted biopsy needle is inserted through the sheath, the device is fired to advance the needle, and the core (range, five to 12) are obtained and submitted for histologic evaluation. Other device (Johnson and Johnson) will be used on current procedure after endorsement. After tissue acquisition is complete, the biopsy device is removed. Postprocedure sagittal T1-weighted imaging is performed to document adequate sampling of the lesion, and to determine the presence of postprocedure hematoma. After procedure, an hour follow-up is performed for patient's stability. Imaging-histologic correlation is performed for all biopsy results to determine concordance.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1) Malignancy is highly suspected among MRI only visible lesions (we have diagnostic criteria).
2) Over twenty years-old.
3) Performance status is 0 to 2.
4) An informed consent was obtained from all patients after they had been provided with a detailed explanation about the procedure.

Key exclusion criteria

1) Positive for HBs antigen or HCV antibody.
2) History of allergy for contrast medium (Gd-DTPA).
3) Serious heart disease or arrhythmia.
4) Serious liver dysfunction (AST or ALT over 100 IU/L)
5) Serious renal dysfunction (eGFR under 40 ml/min.)
6) During anti-coagulant 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

44

Name of lead principal investigator

1st name	Shigeki
Middle name
Last name	Kobayashi

Organization

Mie University Hospital

Division name

Healthscience Center

Zip code

514-8507

Address

2-174 Edobashi, Tsu, Mie, 514-8507 JAPAN

TEL

059-232-1111

Email

koba@mri-gw.medic.mie-u.ac.jp

Name of contact person

1st name	Shigeki
Middle name
Last name	Kobayashi

Organization

Mie University Hospital

Division name

Healthscience Center

Zip code

514-8507

Address

2-174 Edobashi, Tsu, Mie, 514-8507 JAPAN

TEL

059-232-1111

Homepage URL

Email

koba@mri-gw.medic.mie-u.ac.jp

Institute

Mie University Hospital

Institute

Department

Personal name

Organization

Bayer Schering Pharma

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Clinical Research Support Center

Address

2-174 Edobashi, Tsu, Mie, 514-8507 JAPAN

Tel

059-231-5246

Email

koba@mri-gw.medic.mie-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

三重大学医学部附属病院

Date of disclosure of the study information

2010

Year

10

Month

18

Day

URL releasing protocol

no URL was released

Publication of results

Unpublished

URL related to results and publications

no URL was released

Number of participants that the trial has enrolled

9

Results

9 cases were performed of VAB using MRI.
Those ages were ranged from 43 to 70 years old ( mean age 55.2).
MRI findings were 2 cases of category 3, 7 cases of category 4.
The pathological results were DCIS of 2 cases, precancerous lesion of 3 cases, 4 cases of benign.
Although all nine cases had bleeding for procedures, there was no case that serious event occurred.

Results date posted

2019

Year

06

Month

13

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

All cases were performance status 1.
All cases were detected greater than category 3, and lesions were not detected on 2nd look ultra-sonography by breast surgeon.
Written informed consent was obtained in all cases.

Participant flow

Written informed consent was obtained in all subjects, and blood tests were done on same day.
Clinical trial was performed on ambulatory practice, all subjects had no serious event for this trial.
After a week, pathological results were explained by breast surgeons.
When the results was benign, following-up was continued at least a year by breast surgeons.

Adverse events

There was no serious event in all subjects.

Outcome measures

Incident rate of malignant lesion.
Serious event
NPV
Success rate for VAB
Operative method

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2010

Year

08

Month

27

Day

Date of IRB

2010

Year

10

Month

01

Day

Anticipated trial start date

2010

Year

11

Month

01

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

09

Month

24

Day

Last modified on

2019

Year

06

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005076