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 the localization of breast cancer with non-mass enhancement in breast conserving surgery (prospective multicenter study) : FUSION 02 study
Acronym	FUSION 02 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 the localization of breast cancer with non-mass enhancement in breast conserving surgery (prospective multicenter study) : FUSION 02 study
Scientific Title:Acronym	FUSION 02 study
Region	Japan

Condition
Condition	Breast cancer with non-mass enhancement (NME) detected by MRI
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether Real-time virtual sonography (RVS)/Volume navigation (Vnav) contribute to the improvement of margin positive rate of breast cancer with NME in breast conserving surgery by prospective multicenter cohort study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	The rate of margin positive after pre-operative marking using RVS/Vnav in breast conserving surgery for breast cancer with NME
Key secondary outcomes	1) The detection rate of NME in supine MRI 2) The required time to detect the border of the area of NME by using RVS/Vnav 3) The required time to put the breast tissue marker at the border of the area NME 4) The detection rate of the breast tissue marker by the pre-operative ultrasound 5) Operation time and weight of resected specimen in breast conserving surgery, 6) Distance between breast tissue marker and pathological surgical margin 7) The re-operation rate and re-operation operative method

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Fusion imaging technique using Ultrasound ( RVS / Vnav )
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 a breast cancer with NME 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 is not able to perform breast MRI with some reasons. 9) A patient who is pregnant or a patient who has a possibility of being pregnant 10) A patient who is lactating 11) A patient who is not able to perform breast conserving surgery 12) A patient who has a history of mental disorder or central nervous disorder 13) A patient who was received neoadjuvant chemotherapy. 14) A patient with allergy for a titanium 15) A patient with allergy for a xylocaine 16) A patient who is not considered suitable by doctors
Target sample size	30

Research contact person
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
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	snakano1@aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University
Institute
Department

Funding Source
Organization	Aichi Medical University
Organization
Division
Category of Funding Organization	Other
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	0561-62-3311
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）、大垣市民病院（岐阜県）

Other administrative information
Date of disclosure of the study information	2019 Year 09 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	Open public recruiting
Date of protocol fixation	2019 Year 02 Month 17 Day
Date of IRB	2019 Year 02 Month 28 Day
Anticipated trial start date	2019 Year 03 Month 12 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 18 Day
Last modified on	2020 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041633