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NCT Number: NCT03202472

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

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Lesion Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implanted Medical Device

Device

Radiofrequency tag

Other names: IMPLANTED

Mammography

Procedure

Undergo mammogram for image-guided placement of radiofrequency tag

Questionnaire Administration

Other

Ancillary studies

Radiofrequency (RFID) -Guided Localization

Procedure

Undergo radiofrequency-guided localization

Other names: RFID Localization, RFID-Guided Localization

Ultrasonography

Procedure

Undergo ultrasound for image-guided placement of radiofrequency tag

Other names: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical, US

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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:

    • Strongly disagree
    • Disagree
    • Neutral
    • Agree
    • 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.

  3. Patients With Cancer Requiring Re-excision

    Time frame: up to 4 weeks post initial surgery

    Patients requiring re-excision.

  4. 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

  5. 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.

  6. 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:

    • Strongly disagree
    • Disagree
    • Neutral
    • Agree
    • 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.

  7. 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:

    • Strongly disagree
    • Disagree
    • Neutral
    • Agree
    • 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 28, 2017
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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