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

July 22, 2020 updated by: Jonsson Comprehensive Cancer Center

Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

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
    • California
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • Multicentric breast cancer
  • Stage IV breast cancer
  • Pregnant or lactating females

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 mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.
Other: Questionnaire Administration
Ancillary studies
Device: Implanted Medical Device
Radiofrequency tag
Other Names:
  • IMPLANTED
Procedure: Mammography
Undergo mammogram for image-guided placement of radiofrequency tag
Procedure: Radiofrequency (RFID) -Guided Localization
Undergo radiofrequency-guided localization
Other Names:
  • RFID Localization
  • RFID-Guided Localization
Procedure: Ultrasonography
Undergo ultrasound for image-guided placement of radiofrequency tag
Other Names:
  • 2-Dimensional Grayscale Ultrasound Imaging
  • 2-Dimensional Ultrasound Imaging
  • 2D-US
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US
  • ULTRASOUND

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography
Time Frame: at time of device placement, confirmed by mammography
Patients with successful radiofrequency tag placement
at time of device placement, confirmed by mammography
Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography
Time Frame: at time of surgery, within 30 days of tag implant
Patients with successful radiofrequency tag retrieval.
at time of surgery, within 30 days of tag implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days Prior to Surgery of Insertion of Marker
Time Frame: Up to 30 days prior to surgery
Mean number of days before surgery that radiofrequency tag was placed.
Up to 30 days prior to surgery
Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire
Time Frame: within 24 hours of device placement

The patient experience with image-guided placement of the radio frequency Identification (RFID) tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire:

  1. Strongly disagree
  2. Disagree
  3. Neutral
  4. Agree
  5. Strongly Agree

Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response.
within 24 hours of device placement
Patients With Cancer Requiring Re-excision
Time Frame: up to 4 weeks post initial surgery
Patients requiring re-excision.
up to 4 weeks post initial surgery
Patients With Documented Migration of Marker
Time Frame: at time of surgery, within 30 days of tag implant
Movement of radiofrequency tag from point of placement
at time of surgery, within 30 days of tag implant
Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology
Time Frame: at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
Patients with margins of excisable tissue remaining.
at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire
Time Frame: within 24 hours of device placement

The radiologist's experience with image-guided placement of the RFID tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire:

  1. Strongly disagree
  2. Disagree
  3. Neutral
  4. Agree
  5. Strongly Agree

Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response.
within 24 hours of device placement
Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire
Time Frame: within 24 hours of surgery

The surgeon's experience with image-guided placement of the RFID tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire:

  1. Strongly disagree
  2. Disagree
  3. Neutral
  4. Agree
  5. Strongly Agree

Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response.
within 24 hours of surgery
Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken)
Time Frame: at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
Amount of tissue removed with radiofrequency tag.
at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery

Collaborators and Investigators

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

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Maggie DiNome, MD, UCLA / Jonsson Comprehensive Cancer Center

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)

August 3, 2017

Primary Completion (Actual)

January 12, 2018

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

July 24, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-000668 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center)
  • NCI-2017-01097 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • UCLA LOCalizer 00 I

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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