UMIN-CTR Clinical Trial

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

MRI-detected lesion of the breast

Classification by specialty

Breast surgery

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Aichi Medical University

Address

1-1, Yazakokarimata, Nagate-city, Aichi, Japan

Tel

480-1195

Email

snakano1@aichi-med-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

愛知医科大学病院（愛知県）

Date of disclosure of the study information

2014

Year

08

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

08

Month

25

Day

Last modified on

2019

Year

05

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017394