Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy

A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions

This pilot clinical trial studies the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). The radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.

PRIMARY OBJECTIVES:

I. To obtain human clinical data in order to demonstrate that the Radiofrequency Identification (RFID) Localization System performs as intended as a localization device for marking and retrieving a surgical target in the breast.

SECONDARY OBJECTIVES:

I. To solicit feedback from the radiologists and surgeons regarding the process and use of the RFID system.

OUTLINE:

Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.

Inclusion Criteria:

• Have had stereotactic or ultrasound-guided biopsy with marker placement
• Have a lesion or biopsy marker that is visible under ultrasound
• Have a surgical target =< 6 cm from the skin when lying supine
• Have a discreet surgical target
• Have a lesion in which the center/focal area is defined
• Have the ability to understand and the willingness to sign a written informed consent document
• Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an inclusion criterion
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Require more than one localization needle for localization of the surgical target (bracket localization)
• Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast
• Have a prosthesis/implant in the operative breast
• Have a cardiac pacemaker or defibrillator device
• Be contraindicated for surgery
• Be pregnant