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 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).

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014952

Enrollment

Registered

2014-08-26

Start date

2014-08-26

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

MRI-detected lesion of the breast

Interventions

Image fusion technique using magnetic position tracking system (RVS or Vnavi)

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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 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

Design outcomes

Primary

Measure	Time frame
Success rate of tissue sampling by vacuum assisted biopsy using second-look US with RVS/Vnavi for MRI-detected lesion	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactShogo Nakano

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

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

Outcome results

None listed

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