Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy
Trial ID or NCT#
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.
A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions
- - 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
- - 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
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