UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004820 |
|---|---|
| Receipt number | 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 19:48:10 |
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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
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
Sponsor or person
Institute
Tokyo Medical and Dental 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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005738
