UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017321 |
|---|---|
| Receipt number | R000020099 |
| Scientific Title | Volume Navigation System Guided Breast Biopsy for Incidental Enhancing Lesions Detected by MRI |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2019/08/20 16:35:31 |
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Basic information
Public title
Volume Navigation System Guided Breast Biopsy for Incidental Enhancing Lesions Detected by MRI
Acronym
V-NAVI
Scientific Title
Volume Navigation System Guided Breast Biopsy for Incidental Enhancing Lesions Detected by MRI
Scientific Title:Acronym
V-NAVI
Region
| Japan |
Condition
Condition
Incidental Enhancing Lesions (IEL) Detected by MRI
Classification by specialty
| Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this retrospective study was to evaluate the feasibility of V-Navi-guided biopsy method as an IEL diagnostic procedure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The accuracy of V-Navi-guided biopsy method as an IEL diagnostic procedure
Key secondary outcomes
Base
Study type
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
| Maneuver |
Interventions/Control_1
The patients performed VNavi guided biopsy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with IEL
Key exclusion criteria
the patients without informed consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | hirofumi kawakubo |
Organization
Keio University School of Medicine
Division name
Surgery
Zip code
Address
35 Shinanomachi Shinjuku
TEL
0333531211
hkawakubo@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MAIKO TAKAHASHI |
Organization
Keio University Hospital
Division name
Cancer Center
Zip code
Address
35 Shinanomachi Shinjuku
TEL
0333531211
Homepage URL
maiko0118@gmail.com
Sponsor or person
Institute
Keio 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
| 2015 | Year | 05 | Month | 01 | 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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 20 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 29 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020099
