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

Not Applicable

Completed

Conditions: Lesion
Breast Neoplasm

Interventions: Device: Implanted Medical Device
Procedure: Mammography
Other: Questionnaire Administration
Procedure: Radiofrequency (RFID) -Guided Localization
Procedure: Ultrasonography

Registration Number: NCT03202472

Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (radiofrequency-guided localization)	Mammography	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.
Diagnostic (radiofrequency-guided localization)	Radiofrequency (RFID) -Guided Localization	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.
Diagnostic (radiofrequency-guided localization)	Implanted Medical Device	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.
Diagnostic (radiofrequency-guided localization)	Questionnaire Administration	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.
Diagnostic (radiofrequency-guided localization)	Ultrasonography	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology	at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery	Patients with margins of excisable tissue remaining.
Days Prior to Surgery of Insertion of Marker	Up to 30 days prior to surgery	Mean number of days before surgery that radiofrequency tag was placed.
Patients With Cancer Requiring Re-excision	up to 4 weeks post initial surgery	Patients requiring re-excision.
Patients With Documented Migration of Marker	at time of surgery, within 30 days of tag implant	Movement of radiofrequency tag from point of placement
Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire	within 24 hours of device placement	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: 1. Strongly disagree 2. Disagree 3. Neutral 4. Agree 5. 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.
Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire	within 24 hours of surgery	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: 1. Strongly disagree 2. Disagree 3. Neutral 4. Agree 5. 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.
Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire	within 24 hours of device placement	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: 1. Strongly disagree 2. Disagree 3. Neutral 4. Agree 5. 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.
Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken)	at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery	Amount of tissue removed with radiofrequency tag.