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

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 - FUSION 02 study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036540

Enrollment

Registered

2019-09-01

Start date

2019-03-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer with non-mass enhancement (NME) detected by MRI

Interventions

Fusion imaging technique using Ultrasound ( RVS / Vnav )

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The rate of margin positive after pre-operative marking using RVS/Vnav in breast conserving surgery for breast cancer with NME	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactShogo Nakano

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

snakano1@aichi-med-u.ac.jp0561-62-3311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026