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

N/ACompletedNCT03202472

Jonsson Comprehensive Cancer Center50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Neoplasm Lesion

Interventions

Implanted Medical DeviceDEVICE

Radiofrequency tag

MammographyPROCEDURE

Undergo mammogram for image-guided placement of radiofrequency tag

Questionnaire AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography

Patients with successful radiofrequency tag placement

Time frame: 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.

Time frame: at time of surgery, within 30 days of tag implant

Secondary Outcomes

Days Prior to Surgery of Insertion of Marker

Mean number of days before surgery that radiofrequency tag was placed.

Time frame: 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: 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.

Time frame: within 24 hours of device placement

Patients With Cancer Requiring Re-excision

Patients requiring re-excision.

Time frame: up to 4 weeks post initial surgery

Patients With Documented Migration of Marker

Data from ClinicalTrials.gov

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