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
- Conditions
- Breast cancer with non-mass enhancement (NME) detected by MRI
- Registration Number
- JPRN-UMIN000036540
- Lead Sponsor
- Aichi Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 30
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of margin positive after pre-operative marking using RVS/Vnav in breast conserving surgery for breast cancer with NME
- Secondary Outcome Measures
Name Time Method 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