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

January 31, 2017 updated by: Stanford University

A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Lumpectomy
Undergo lumpectomy
Other Names:
  • Lumpectomy of Breast
  • partial mastectomy
Procedure: Radiofrequency-Guided Localization
Undergo radiofrequency-guided localization

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feedback solicited from the radiologist and surgeon
Time Frame: 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.
Up to 12 months after lumpectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jafi Lipson, Stanford University Hospitals and Clinics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

May 1, 2015

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRS0053 (Other Identifier: Stanford University Hospitals and Clinics)
  • P30CA124435 (U.S. NIH Grant/Contract)
  • 348
  • NCI-2015-00630 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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