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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004260
Receipt No. R000005076
Scientific Title MR-guided vacuum assisted biopsy for MRI-only visible lesion.
Date of disclosure of the study information 2010/10/18
Last modified on 2019/06/13

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Basic information
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
Condition MRI-only visible lesion
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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)

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 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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Mie University Hospital
Institute
Department

Funding Source
Organization Bayer Schering Pharma
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 三重大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 18 Day

Related information
URL releasing protocol no URL was released
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2010 Year 09 Month 24 Day
Last modified on
2019 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005076

Research Plan
Registered date File name
2019/06/12 920100724_BIRUMM-01_Ver08_Nov2016_clean copy.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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