The Evaluation in usefulness of Guiding Marker SystemTM and magnetic probe, for detecting and resecting of non-palpable lesions of the breast

JRCT ID: jRCTs032180422

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 05/01/2019
• Target sample size: 33
• Study type: Interventional

Intervention(s)

Puncture and insertion of guiding marker
Resection of non palpable lesion of breast

Outcome(s)

• Primary Outcome: Complete resection of guiding marker

Secondary Outcome

Positive rate of the surgical margin
Re-operation / boost radiation within 3 months after breast conserving surgery
Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1.Non-palpable breast cancer or non-palpable lesion suspected breast cancer which is planed surgical procedure.
2.Over 20 years old when its consented
3.Written informed consent

Exclude criteria

1.Metal allergy
2.Patient who had breast implant insertion surgery
3.Breast cancer patient in pregnancy period or lactation period
4.Male breast cancer
5.Inflammatory breast cancer
6.Patient who is assessed not applicable by physicians

Related Information

• Primary Sponsor: Takeo Hiroyuki
• Secondary Sponsor: Kusakabe Moriaki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development