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

Primary Purpose

Breast Neoplasm, Lesion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implanted Medical Device
Mammography
Questionnaire Administration
Radiofrequency (RFID) -Guided Localization
Ultrasonography
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasm

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (radiofrequency-guided localization)

Arm Description

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.

Outcomes

Primary Outcome Measures

Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography
Patients with successful radiofrequency tag placement
Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography
Patients with successful radiofrequency tag retrieval.

Secondary Outcome Measures

Days Prior to Surgery of Insertion of Marker
Mean number of days before surgery that radiofrequency tag was placed.
Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire
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.
Patients With Cancer Requiring Re-excision
Patients requiring re-excision.
Patients With Documented Migration of Marker
Movement of radiofrequency tag from point of placement
Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology
Patients with margins of excisable tissue remaining.
Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire
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.
Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire
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.
Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken)
Amount of tissue removed with radiofrequency tag.

Full Information

First Posted
June 26, 2017
Last Updated
July 22, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT03202472
Brief Title
Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery
Official Title
Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
January 12, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Lesion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (radiofrequency-guided localization)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Implanted Medical Device
Other Intervention Name(s)
IMPLANTED
Intervention Description
Radiofrequency tag
Intervention Type
Procedure
Intervention Name(s)
Mammography
Intervention Description
Undergo mammogram for image-guided placement of radiofrequency tag
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency (RFID) -Guided Localization
Other Intervention Name(s)
RFID Localization, RFID-Guided Localization
Intervention Description
Undergo radiofrequency-guided localization
Intervention Type
Procedure
Intervention Name(s)
Ultrasonography
Other Intervention Name(s)
2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical, US
Intervention Description
Undergo ultrasound for image-guided placement of radiofrequency tag
Primary Outcome Measure Information:
Title
Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography
Description
Patients with successful radiofrequency tag placement
Time Frame
at time of device placement, confirmed by mammography
Title
Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography
Description
Patients with successful radiofrequency tag retrieval.
Time Frame
at time of surgery, within 30 days of tag implant
Secondary Outcome Measure Information:
Title
Days Prior to Surgery of Insertion of Marker
Description
Mean number of days before surgery that radiofrequency tag was placed.
Time Frame
Up to 30 days prior to surgery
Title
Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire
Description
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.
Time Frame
within 24 hours of device placement
Title
Patients With Cancer Requiring Re-excision
Description
Patients requiring re-excision.
Time Frame
up to 4 weeks post initial surgery
Title
Patients With Documented Migration of Marker
Description
Movement of radiofrequency tag from point of placement
Time Frame
at time of surgery, within 30 days of tag implant
Title
Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology
Description
Patients with margins of excisable tissue remaining.
Time Frame
at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
Title
Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire
Description
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.
Time Frame
within 24 hours of device placement
Title
Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire
Description
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.
Time Frame
within 24 hours of surgery
Title
Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken)
Description
Amount of tissue removed with radiofrequency tag.
Time Frame
at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maggie DiNome, MD
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30689105
Citation
DiNome ML, Kusske AM, Attai DJ, Fischer CP, Hoyt AC. Microchipping the breast: an effective new technology for localizing non-palpable breast lesions for surgery. Breast Cancer Res Treat. 2019 May;175(1):165-170. doi: 10.1007/s10549-019-05143-w. Epub 2019 Jan 28.
Results Reference
derived

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

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