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

Not Applicable

Withdrawn

• Conditions: Breast Neoplasm
• Interventions: Procedure: Lumpectomy; Other: Questionnaire Administration; Procedure: Radiofrequency-Guided Localization

• Registration Number: NCT02432118
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-04-28
• Study Start: 2015-05
• Study First Posted: 2015-05-01
• Primary Completion: 2016-02
• Study Completion: 2016-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (radiofrequency-guided localization)	Questionnaire Administration	Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.
Diagnostic (radiofrequency-guided localization)	Radiofrequency-Guided Localization	Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.
Diagnostic (radiofrequency-guided localization)	Lumpectomy	Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.

Primary Outcome Measures

Name	Time	Method
Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast	At time of surgery	Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions.

Secondary Outcome Measures

Name	Time	Method
Feedback solicited from the radiologist and surgeon	Up to 12 months after lumpectomy	Feedback solicited from the radiologist and surgeon will be summarized using qualitative methods. Each questionnaire will be reviewed for both positive and negative responses and summarized.