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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004820
Receipt No. R000005738
Scientific Title Feasibility study of MRI guided breast biopsy
Date of disclosure of the study information 2011/01/05
Last modified on 2018/10/10

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Basic information
Public title Feasibility study of MRI guided breast biopsy
Acronym MRI guided breast biopsy
Scientific Title Feasibility study of MRI guided breast biopsy
Scientific Title:Acronym MRI guided breast biopsy
Region
Japan

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

Objectives
Narrative objectives1 Feasibility and safty of MR-guided breast biopsy is evaluated by the approved devices.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Safty of the procedure.
Key secondary outcomes Possibility of pathological diagnosis.
Feasibility of the procedure.

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 Follow up term:6 months.
After contrast enhanced MRI, local anesthesia is performed, handheld vacuum assisted biopsy needle (BIRD Vacora biopsy system)is inserted, adjusted, and biopsy is performed.
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 Male and Female
Key inclusion criteria 1) breast cancer is suspected on contrast enhanced MRI.
2) the lesion is not identified on ultrasound or mammography.
3) an informed consent was obtained after a detailed explanation.
Key exclusion criteria 1) MRI examination is impossible.
2) History of allergy for GD-DTPA contrast medium.
3) During anti-coagulant therapy.
4) Hemorrhagic diathesis.
5) Staff decides inadequate case for current study.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Kubota
Organization Tokyo Medical and Dental University Hospital
Division name Department of Radiology
Zip code
Address 1-5-45, Yushima,Bunkyo-ku, Tokyo, 113-8519 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Kubota
Organization Tokyo Medical and Dental University Hospital
Division name Department of Radiology
Zip code
Address 1-5-45, Yushima,Bunkyo-ku, Tokyo,113-8519 JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Tokyo Medical and Dental University Hospital
Institute
Department

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
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
2011 Year 01 Month 05 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
2010 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 05 Day
Last modified on
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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