Unique ID issued by UMIN | UMIN000014952 |
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Receipt number | R000017394 |
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). |
Date of disclosure of the study information | 2014/08/26 |
Last modified on | 2019/05/04 13:04:44 |
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).
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).
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).
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).
Japan |
MRI-detected lesion of the breast
Breast surgery | Radiology |
Malignancy
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Success rate of tissue sampling by vacuum assisted biopsy using second-look US with RVS/Vnavi for MRI-detected lesion
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Device,equipment |
Image fusion technique using magnetic position tracking system (RVS or Vnavi)
20 | years-old | <= |
Not applicable |
Female
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
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
32
1st name | Shogo |
Middle name | |
Last name | Nakano |
Aichi Medical University
Division of Breast and Endocrine Surgery, Department of Surgery
480-1195
1-1, Yazakokarimata, Nagate-city, Aichi, Japan
0561-62-3311
snakano1@aichi-med-u.ac.jp
1st name | Shogo |
Middle name | |
Last name | Nakano |
Aichi Medical University
Division of Breast and Endocrine Surgery, Department of Surgery
480-1195
1-1, Yazakokarimata, Nagate-city, Aichi, Japan
0561-62-3311
nyunaige@aichi-med-u.ac.jp
Division of Breast and Endocrine Surgery, Department of Surgery, Aichi Medical University
Division of Breast and Endocrine Surgery, Department of Surgery, Aichi Medical University
Self funding
Aichi Medical University
1-1, Yazakokarimata, Nagate-city, Aichi, Japan
480-1195
snakano1@aichi-med-u.ac.jp
NO
愛知医科大学病院(愛知県)
2014 | Year | 08 | Month | 26 | Day |
Unpublished
Enrolling by invitation
2014 | Year | 07 | Month | 16 | Day |
2014 | Year | 08 | Month | 26 | Day |
2014 | Year | 08 | Month | 25 | Day |
2019 | Year | 05 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017394
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