Radiofrequency Chip for Localization of Non-Palpable Breast Lesions

August 5, 2022 updated by: Megha Garg, University of Missouri-Columbia

Use of a Radiofrequency Chip for Localization of Non-Palpable Breast Lesions: A Comparison to Wire Localization

The purpose of the project is to compare Radiofrequency identification device (RFID) localization technique with the current clinical standard wire localization technique. The Investigator's hypotheses is that the RFID localization technique is non-inferior to wire localization for breast lesions (tumors).

The study will be conducted in two parts. The purpose of Part A is for physician training with the RFID device. Nine subjects will undergo RFID and wire localization prior to breast lesion excision. This will allow the breast radiologists and surgeons to become comfortable with RFID device placement and retrieval. Additionally, the investigators will pilot the data collection surveys and chart review methodology to be used in Part B.

The purpose of Part B is to conduct a randomized clinical trial to assess whether RFID localization is non-inferior to wire localization for breast lesions. For this part, sixty subjects will be randomized to RFID (N=30) or wire localization (N=30) at time of enrollment. Surveys will be used to gather data from participants, radiologists, surgeons, and technologists/mammography nurses. A variety of data will be collected including, but not limited to, information on tumor size, location, depth; subject demographics; adequacy of tumor margins, re-excision rates, accuracy of wire or chip placement, and surgical complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As part of standard of care, participants will receive: an ultrasound (US) or mammographic guided localization; excisional breast surgery; and a follow-up visit in breast surgery clinic.

As part of the research protocol, participants will receive a RFID chip for the localization procedure and complete surveys.

Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader. Participants, radiologists, surgeons, breast surgery and radiology staff will complete surveys.

Part B of this project is a prospective trial to examine safety, efficacy, operating room utilization patterns, and satisfaction with RFID versus wire localization. Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). Participants will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. Participants, radiologists, surgeons, breast surgery and radiology staff will complete surveys.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri

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

Female

Description

Inclusion Criteria:

  • Women requiring image guided pre-operative breast tumor localization

Exclusion Criteria:

  • Tumors deeper than 6 cm from the skin surface
  • More than one tumor requiring localization
  • Tumors requiring bracketing
  • Tumors requiring Magnetic Resonance Imaging localization
  • Inability to complete survey
  • Pregnancy

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: RFID and Wire Localization
Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader.
Device: RFID and Wire Localization
Both RFID and the standard of care wire localization will be performed for physician training.
Experimental: RFID Localization
Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care.
Device: RFID Localization
The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.
Active Comparator: Wire Localization
Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care.
Device: Wire Localization
The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Successful Localization
Time Frame: From the date of localization through the date of surgery up to 4 weeks; data collected during Visit 3 at time of surgery
Whether the surgeon was able to identify and remove the tumor
From the date of localization through the date of surgery up to 4 weeks; data collected during Visit 3 at time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surveys of Satisfaction: Participant
Time Frame: Data collected during date of localization at Visit 2, up to approximately one month from baseline visit

Survey Question: "Compared to expected, how uncomfortable was the localization?"

Scored on a scale of 1 to 5 with the best being 5
Data collected during date of localization at Visit 2, up to approximately one month from baseline visit
Surveys of Satisfaction
Time Frame: Data collected at baseline during Visit 1

Surveys of Radiology Nurse ease of scheduling the localization procedure.

Scored on a scale of 1 to 5 with the best being 5
Data collected at baseline during Visit 1
Surveys of Satisfaction
Time Frame: Data collected during date of localization at Visit 2, up to approximately one month from baseline visit

Surveys of radiologist satisfaction with the localization procedure.

Scored on a scale of 1 to 5 with the best being 5
Data collected during date of localization at Visit 2, up to approximately one month from baseline visit
Number of Participants With Tumor Incompletely Excised
Time Frame: Surgical resection specimen collected during Visit 3, at time of surgery
Number of participants with positive margin on pathology
Surgical resection specimen collected during Visit 3, at time of surgery

Collaborators and Investigators

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

Sponsor

University of Missouri-Columbia

Collaborators

Health Beacons

Investigators

  • Principal Investigator: Megha Garg, MD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 18, 2018

Primary Completion (Actual)

April 19, 2021

Study Completion (Actual)

April 19, 2021

Study Registration Dates

First Submitted

July 27, 2018

First Submitted That Met QC Criteria

September 21, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011684

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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