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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Procedure: Lumpectomy
* Other: Questionnaire Administration
* Procedure: Radiofrequency-Guided Localization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (radiofrequency-guided localization)<br>Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy. | Procedure: Lumpectomy<br>* Undergo lumpectomy<br>* Other names: partial mastectomy;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Radiofrequency-Guided Localization<br>* Undergo radiofrequency-guided localization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 12 months after lumpectomy |