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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-03

Study Completion Date

2019-02-01

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.

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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.

Conditions

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Breast Neoplasm Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (radiofrequency-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.

Group Type EXPERIMENTAL

Implanted Medical Device

Intervention Type DEVICE

Radiofrequency tag

Mammography

Intervention Type PROCEDURE

Undergo mammogram for image-guided placement of radiofrequency tag

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Radiofrequency (RFID) -Guided Localization

Intervention Type PROCEDURE

Undergo radiofrequency-guided localization

Ultrasonography

Intervention Type PROCEDURE

Undergo ultrasound for image-guided placement of radiofrequency tag

Interventions

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Implanted Medical Device

Radiofrequency tag

Intervention Type DEVICE

Mammography

Undergo mammogram for image-guided placement of radiofrequency tag

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Radiofrequency (RFID) -Guided Localization

Undergo radiofrequency-guided localization

Intervention Type PROCEDURE

Ultrasonography

Undergo ultrasound for image-guided placement of radiofrequency tag

Intervention Type PROCEDURE

Other Intervention Names

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IMPLANTED RFID Localization RFID-Guided Localization 2-Dimensional Grayscale Ultrasound Imaging 2-Dimensional Ultrasound Imaging 2D-US ULTRASOUND Ultrasound Imaging Ultrasound Test Ultrasound, Medical US

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