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

Stanford University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Breast Neoplasm

Interventions

LumpectomyPROCEDURE

Undergo lumpectomy

Questionnaire AdministrationOTHER

Ancillary studies

Radiofrequency-Guided LocalizationPROCEDURE

Undergo radiofrequency-guided localization

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast

Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions.

Time frame: At time of surgery

Secondary Outcomes

Feedback solicited from the radiologist and surgeon

Feedback solicited from the radiologist and surgeon will be summarized using qualitative methods. Each questionnaire will be reviewed for both positive and negative responses and summarized.

Time frame: Up to 12 months after lumpectomy

Data from ClinicalTrials.gov

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