The Evaluation of magnetic probe system for detecting of non-palpable lesions of the breast

JRCT ID: jRCTs032190189

Registered date:20/01/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 20/01/2020
• Target sample size: 42
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Complete resection rate of breast lesions on initial operation

Secondary Outcome

Additional resection rate on initial operation
Positive rate of the surgical margin
Re-operation/boost radiation within 3 months after breast conserving surgery

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: Takei Hiroyuki
• Secondary Sponsor: Kusakabe Moriaki,Matrix Cell Research Institute Inc.
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development