Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery

Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery

This pilot clinical trial studies radiofrequency technology in locating non-palpable breast lesions in patients undergoing surgery. Placing a miniature radiofrequency tag or microchip in the breast lesion before surgery and using a handheld device to guide doctors during surgery may improve surgical outcomes in patients with non-palpable breast lesions.

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of utilizing a new Federal Drug Administration (FDA)-cleared radiofrequency tag for localization of non-palpable breast lesions and provide preliminary data for a larger study.

OUTLINE:

Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.

After completion of study, patients are followed up within 2 weeks.

Inclusion Criteria:

• Able to give written informed consent to participate in the study
• Able to read and write English
• Patients with breast lesions that are non-palpable that require surgical removal
• Lesions and/or clip targetable with image guidance

Exclusion Criteria:

• Multicentric breast cancer
• Stage IV breast cancer
• Pregnant or lactating females