Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery

Study Overview
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Brief Summary
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This pilot clinical trial studies radiofrequency technology in locating non-palpable breast lesions in patients undergoing surgery. Placing a miniature radiofrequency tag or microchip in the breast lesion before surgery and using a handheld device to guide doctors during surgery may improve surgical outcomes in patients with non-palpable breast lesions.

Detailed Description
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PRIMARY OBJECTIVES: I. Evaluate the feasibility of utilizing a new Federal Drug Administration (FDA)-cleared radiofrequency tag for localization of non-palpable breast lesions and provide preliminary data for a larger study. OUTLINE: Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. After completion of study, patients are followed up within 2 weeks.

Official Title
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Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery

Conditions
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Breast Neoplasm, Lesion

Intervention / Treatment
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* Device: Implanted Medical Device
* Procedure: Mammography
* Other: Questionnaire Administration
* Procedure: Radiofrequency (RFID) -Guided Localization
* Procedure: Ultrasonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to give written informed consent to participate in the study Able to read and write English Patients with breast lesions that are non-palpable that require surgical removal Lesions and/or clip targetable with image guidance Exclusion Criteria: Multicentric breast cancer Stage IV breast cancer Pregnant or lactating females

Ages Eligible for Study
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Minimum Age: 19 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 mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. | Device: Implanted Medical Device<br>* Radiofrequency tag<br>* Other names: IMPLANTED;Procedure: Mammography<br>* Undergo mammogram for image-guided placement of radiofrequency tag<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Radiofrequency (RFID) -Guided Localization<br>* Undergo radiofrequency-guided localization<br>* Other names: RFID-Guided Localization;Procedure: Ultrasonography<br>* Undergo ultrasound for image-guided placement of radiofrequency tag<br>* Other names: US;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography | Patients with successful radiofrequency tag placement | at time of device placement, confirmed by mammography | 
| Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography | Patients with successful radiofrequency tag retrieval. | at time of surgery, within 30 days of tag implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days Prior to Surgery of Insertion of Marker | Mean number of days before surgery that radiofrequency tag was placed. | Up to 30 days prior to surgery | 
| Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire | The patient experience with image-guided placement of the radio frequency Identification (RFID) tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire: Strongly disagree Disagree Neutral Agree Strongly Agree Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response. | within 24 hours of device placement | 
| Patients With Cancer Requiring Re-excision | Patients requiring re-excision. | up to 4 weeks post initial surgery | 
| Patients With Documented Migration of Marker | Movement of radiofrequency tag from point of placement | at time of surgery, within 30 days of tag implant | 
| Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology | Patients with margins of excisable tissue remaining. | at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery | 
| Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire | The radiologist's experience with image-guided placement of the RFID tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire: Strongly disagree Disagree Neutral Agree Strongly Agree Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response. | within 24 hours of device placement | 
| Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire | The surgeon's experience with image-guided placement of the RFID tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire: Strongly disagree Disagree Neutral Agree Strongly Agree Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response. | within 24 hours of surgery | 
| Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken) | Amount of tissue removed with radiofrequency tag. | at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery |