Trial Outcomes & Findings for Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery (NCT NCT03202472)

NCT ID: NCT03202472

Last Updated: 2020-07-24

Results Overview

Patients with successful radiofrequency tag placement

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

at time of device placement, confirmed by mammography

Results posted on

2020-07-24

Participant Flow

Dates of recruitment period: Patient consent and enrollment began 9-Aug-2017 and the final surgical procedure was performed 12-Jan-2018. Fifty-five patients were accessed for eligibility. Five patients who initially consented for the study but then withdrew prior to intervention because their surgeries were either cancelled or rescheduled

There are no pre- assignment details to describe

Participant milestones

Participant milestones
Measure	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. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (Radiofrequency-guided Localization) n=50 Participants 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. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag
Age, Continuous	60 years n=50 Participants
Sex: Female, Male Female	50 Participants n=50 Participants
Sex: Female, Male Male	0 Participants n=50 Participants
Region of Enrollment United States	50 Participants n=50 Participants
Imaging Diagnosis Mammogram	26 Participants n=50 Participants
Imaging Diagnosis Ultrasound	24 Participants n=50 Participants
Lesion Diagnosis Benign	17 Participants n=50 Participants
Lesion Diagnosis Cancerous	33 Participants n=50 Participants
Lesion Category Atypical ductal hyperplasia (ADH)	3 Participants n=50 Participants
Lesion Category Ductal carcinoma in situ (DCIS)	5 Participants n=50 Participants
Lesion Category DCIS with microinvasion	1 Participants n=50 Participants
Lesion Category Encapsulated papillary carcinoma	1 Participants n=50 Participants
Lesion Category Fibroadenoma with atypia	1 Participants n=50 Participants
Lesion Category Glomus tumor	1 Participants n=50 Participants
Lesion Category Invasive ductal carcinoma (IDC)	23 Participants n=50 Participants
Lesion Category Invasive lobular carcinoma (ILC)	3 Participants n=50 Participants
Lesion Category Lobular neoplasia	1 Participants n=50 Participants
Lesion Category Papilloma	3 Participants n=50 Participants
Lesion Category Phyllodes, benign	1 Participants n=50 Participants
Lesion Category Radial Scar	5 Participants n=50 Participants
Lesion Category Stromal Fibrosis	2 Participants n=50 Participants

PRIMARY outcome

Timeframe: at time of device placement, confirmed by mammography

Patients with successful radiofrequency tag placement

Outcome measures

Outcome measures
Measure	Diagnostic (Radiofrequency-guided Localization) n=50 Participants 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. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag
Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography	50 Participants

PRIMARY outcome

Timeframe: at time of surgery, within 30 days of tag implant

Patients with successful radiofrequency tag retrieval.

Outcome measures

Outcome measures
Measure	Diagnostic (Radiofrequency-guided Localization) n=50 Participants 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. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag
Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography	50 Participants

SECONDARY outcome

Timeframe: Up to 30 days prior to surgery

Mean number of days before surgery that radiofrequency tag was placed.

Outcome measures

Outcome measures
Measure	Diagnostic (Radiofrequency-guided Localization) n=50 Participants 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. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag
Days Prior to Surgery of Insertion of Marker	1.4 days Standard Deviation 2.8

SECONDARY outcome

Timeframe: within 24 hours of device placement

Population: All Patients

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.

Outcome measures

Outcome measures
Measure	Diagnostic (Radiofrequency-guided Localization) n=50 Participants 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. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag
Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire	21.3 units on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: up to 4 weeks post initial surgery

Patients requiring re-excision.

Outcome measures

Outcome measures
Measure	Diagnostic (Radiofrequency-guided Localization) n=50 Participants 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. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag
Patients With Cancer Requiring Re-excision	2 Participants

SECONDARY outcome

Timeframe: at time of surgery, within 30 days of tag implant

Movement of radiofrequency tag from point of placement

Outcome measures

Outcome measures
Measure	Diagnostic (Radiofrequency-guided Localization) n=50 Participants 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. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag
Patients With Documented Migration of Marker	0 Participants

SECONDARY outcome

Timeframe: at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery

Patients with margins of excisable tissue remaining.

Outcome measures

Outcome measures
Measure	Diagnostic (Radiofrequency-guided Localization) n=50 Participants 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. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag
Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diagnostic (Radiofrequency-guided Localization) n=50 Participants 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. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag
Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire	20.4 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diagnostic (Radiofrequency-guided Localization) n=50 Participants 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. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag
Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire	21.5 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery

Amount of tissue removed with radiofrequency tag.

Outcome measures

Outcome measures
Measure	Diagnostic (Radiofrequency-guided Localization) n=50 Participants 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. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag
Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken)	30.7 CM3 Standard Deviation 26.4

Adverse Events

Diagnostic (Radiofrequency-guided Localization)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Glover

Jonsson Comprehensive Cancer Center

Phone: 310 794-8742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place