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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-05-31

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.

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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.

Conditions

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Breast Neoplasm

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 radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.

Group Type EXPERIMENTAL

Lumpectomy

Intervention Type PROCEDURE

Undergo lumpectomy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Radiofrequency-Guided Localization

Intervention Type PROCEDURE

Undergo radiofrequency-guided localization

Interventions

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Lumpectomy

Undergo lumpectomy

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Radiofrequency-Guided Localization

Undergo radiofrequency-guided localization

Intervention Type PROCEDURE

Other Intervention Names

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Lumpectomy of Breast partial mastectomy

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No