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

Breast Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202472
• Other study ID #: 17-000668
• Secondary ID: NCI-2017-01097UC
• Status: Completed
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: June 2020
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 1, 2019
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Lesion

Intervention

Device:
• Implanted Medical Device
Radiofrequency tag

Procedure:
• Mammography
Undergo mammogram for image-guided placement of radiofrequency tag

Other:
• Questionnaire Administration
Ancillary studies

Procedure:
• Radiofrequency (RFID) -Guided Localization
Undergo radiofrequency-guided localization
• Ultrasonography
Undergo ultrasound for image-guided placement of radiofrequency tag

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography	Patients with successful radiofrequency tag placement	at time of device placement, confirmed by mammography
Primary	Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography	Patients with successful radiofrequency tag retrieval.	at time of surgery, within 30 days of tag implant
Secondary	Days Prior to Surgery of Insertion of Marker	Mean number of days before surgery that radiofrequency tag was placed.	Up to 30 days prior to surgery
Secondary	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.	within 24 hours of device placement
Secondary	Patients With Cancer Requiring Re-excision	Patients requiring re-excision.	up to 4 weeks post initial surgery
Secondary	Patients With Documented Migration of Marker	Movement of radiofrequency tag from point of placement	at time of surgery, within 30 days of tag implant
Secondary	Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology	Patients with margins of excisable tissue remaining.	at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
Secondary	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.	within 24 hours of device placement
Secondary	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.	within 24 hours of surgery
Secondary	Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken)	Amount of tissue removed with radiofrequency tag.	at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery