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

Trial ID or NCT#

NCT02432118

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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

Investigator(s)

Jafi A Lipson
Jafi A Lipson
Radiologist, Diagnostic radiologist

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Contact

Sumita Sood
650-723-0186