UMIN-CTR Clinical Trial

Basic information
Public title	A validation study of efficacy of image fusion technique using magnetic position tracking system (Real-time virtual sonography or Volume navigation) for sonographic identification of MRI-detected lesion of the breast (prospective multicenter cohort study).
Acronym	A validation study of efficacy of image fusion technique (Real-time virtual sonography or Volume navigation) for sonographic identification of MRI-detected lesion of the breast (prospective multicenter cohort study: FUSION 01 study).
Scientific Title	A validation study of efficacy of image fusion technique using magnetic position tracking system (Real-time virtual sonography or Volume navigation) for sonographic identification of MRI-detected lesion of the breast (prospective multicenter cohort study).
Scientific Title:Acronym	A validation study of efficacy of image fusion technique (Real-time virtual sonography or Volume navigation) for sonographic identification of MRI-detected lesion of the breast (prospective multicenter cohort study: FUSION 01 study).
Region	Japan

Condition
Condition	MRI-detected lesion of the breast
Classification by specialty	Breast surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate useful of second-look US with Real-time virtual sonography (RVS)/Volume navigation (Vnavi) for sonography-guided biopsy of MRI-detected lesion in breast.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Success rate of tissue sampling by vacuum assisted biopsy using second-look US with RVS/Vnavi for MRI-detected lesion
Key secondary outcomes	1) Sonographic detection rate of MRI-detected lesion using second-look US with RVS/Vnavi 2) Safety of RVS/Vnavi 3) Time to detect MRI-detected lesion using second-look US with RVS/Vnavi

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	Image fusion technique using magnetic position tracking system (RVS or Vnavi)
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) A patient who has an MRI-detected lesion in breast MRI examination 2) Female aged over 20 years old 3) Performance status 0-1 4) Agreement on informed consent for this clinical trial
Key exclusion criteria	1) A patient with a pacemaker 2) A patient with allergy for a contrast medium for MRI 3) A patient with a metallic artificial heart valve 4) A patient with past asthmatic symptom 5) A patient with a severe renal dysfunction 6) A patient with a severe claustrophobia 7) A patient with a tattoo 8) A patient who needs follow-up with expander included magnet 9) A patient who is not able to perform breast MRI with some reasons 10) A patient who is not able to perform VAB 11) A patient who is pregnant or a patient who has a possibility of being pregnant 12) A patient who is lactating 13) A patient who has a history of mental disorder or central nervous disorder 14) A patients who is not considered suitable by the doctor
Target sample size	32

Research contact person
Last name of lead principal investigator	1st name Shogo Middle name Last name Nakano
Organization	Aichi Medical University
Division name	Division of Breast and Endocrine Surgery, Department of Surgery
Zip code	480-1195
Address	1-1, Yazakokarimata, Nagate-city, Aichi, Japan
TEL	0561-62-3311
Email	snakano1@aichi-med-u.ac.jp

Public contact
1st name of contact person	1st name Shogo Middle name Last name Nakano
Organization	Aichi Medical University
Division name	Division of Breast and Endocrine Surgery, Department of Surgery
Zip code	480-1195
Address	1-1, Yazakokarimata, Nagate-city, Aichi, Japan
TEL	0561-62-3311
Homepage URL
Email	nyunaige@aichi-med-u.ac.jp

Sponsor
Institute	Division of Breast and Endocrine Surgery, Department of Surgery, Aichi Medical University
Institute
Department

Funding Source
Organization	Division of Breast and Endocrine Surgery, Department of Surgery, Aichi Medical University
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	Aichi Medical University
Address	1-1, Yazakokarimata, Nagate-city, Aichi, Japan
Tel	480-1195
Email	snakano1@aichi-med-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	愛知医科大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 26 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	Enrolling by invitation
Date of protocol fixation	2014 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date	2014 Year 08 Month 26 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	2014 Year 08 Month 25 Day
Last modified on	2019 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017394