UMIN-CTR Clinical Trial

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
Email	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
Email	maiko0118@gmail.com

Sponsor
Institute	Keio 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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020099