Trial Outcomes & Findings for Radiofrequency Chip for Localization of Non-Palpable Breast Lesions (NCT NCT03684408)

NCT ID: NCT03684408

Last Updated: 2022-08-25

Results Overview

Whether the surgeon was able to identify and remove the tumor

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: From the date of localization through the date of surgery up to 4 weeks; data collected during Visit 3 at time of surgery
• Results posted on: 2022-08-25

Participant Flow

Participant milestones

Measure	RFID and Wire Localization Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader. RFID and Wire Localization: Both RFID and the standard of care wire localization will be performed for physician training.	RFID Localization Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. RFID Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.	Wire Localization Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. Wire Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.
Overall Study STARTED	10	16	12
Overall Study COMPLETED	9	15	12
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiofrequency Chip for Localization of Non-Palpable Breast Lesions

Baseline characteristics by cohort

Measure	RFID and Wire Localization n=9 Participants Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader. RFID and Wire Localization: Both RFID and the standard of care wire localization will be performed for physician training.	RFID Localization n=15 Participants Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. RFID Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.	Wire Localization n=12 Participants Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. Wire Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	12 Participants n=7 Participants	7 Participants n=5 Participants	26 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	35 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: From the date of localization through the date of surgery up to 4 weeks; data collected during Visit 3 at time of surgery

Whether the surgeon was able to identify and remove the tumor

Outcome measures

Measure	RFID and Wire Localization n=9 Participants Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader. RFID and Wire Localization: Both RFID and the standard of care wire localization will be performed for physician training.	RFID Localization n=15 Participants Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. RFID Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.	Wire Localization n=12 Participants Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. Wire Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.
Number of Participants With Successful Localization	9 Participants	15 Participants	12 Participants

SECONDARY outcome

Timeframe: Data collected during date of localization at Visit 2, up to approximately one month from baseline visit

Survey Question: "Compared to expected, how uncomfortable was the localization?"

Scored on a scale of 1 to 5 with the best being 5

Outcome measures

Measure	RFID and Wire Localization n=9 Participants Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader. RFID and Wire Localization: Both RFID and the standard of care wire localization will be performed for physician training.	RFID Localization n=15 Participants Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. RFID Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.	Wire Localization n=12 Participants Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. Wire Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.
Surveys of Satisfaction: Participant	3.4 score on a scale Standard Deviation 0.72	3.7 score on a scale Standard Deviation 0.85	4.4 score on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: Data collected at baseline during Visit 1

Population: Not relevant for Part A. Since our breast surgeons were not experienced with using the RFID device, Part A consisted of performing the procedure with the RFID device prior to starting data collection for this outcome. This was done so that the surgeons would have completed their learning curve on a new device before data collection for this outcome began.

Surveys of Radiology Nurse ease of scheduling the localization procedure.

Scored on a scale of 1 to 5 with the best being 5

Outcome measures

Measure	RFID and Wire Localization Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader. RFID and Wire Localization: Both RFID and the standard of care wire localization will be performed for physician training.	RFID Localization n=15 Participants Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. RFID Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.	Wire Localization n=12 Participants Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. Wire Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.
Surveys of Satisfaction	—	4 score on a scale Standard Deviation 0.51	4 score on a scale Standard Deviation 1.22

SECONDARY outcome

Timeframe: Data collected during date of localization at Visit 2, up to approximately one month from baseline visit

Population: Not applicable to part A. Since our breast surgeons were not experienced with using the RFID device, Part A consisted of performing the procedure with the RFID device prior to starting data collection for this outcome. This was done so that the surgeons would have completed their learning curve on a new device before data collection for this outcome began.

Surveys of radiologist satisfaction with the localization procedure.

Scored on a scale of 1 to 5 with the best being 5

Outcome measures

Measure	RFID and Wire Localization Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader. RFID and Wire Localization: Both RFID and the standard of care wire localization will be performed for physician training.	RFID Localization n=15 Participants Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. RFID Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.	Wire Localization n=12 Participants Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. Wire Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.
Surveys of Satisfaction	—	4 score on a scale Standard Deviation 1.28	5 score on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: Surgical resection specimen collected during Visit 3, at time of surgery

Number of participants with positive margin on pathology

Outcome measures

Measure	RFID and Wire Localization n=9 Participants Part A of this project is for physician training to master the technique of RFID placement and retrieval. On the day of surgery prior to going to the operating room, all participants will have the RFID placed first to allow radiologists to become familiar with placement of the RFID localizer. Participants will then immediately undergo wire localization. Either ultrasound or mammogram guidance will be used for the localization at the discretion of the performing radiologist. Surgeons will use a reader to locate the RFID chip during surgery. The wire will be present in the event the area of concern cannot be adequately located with the reader. RFID and Wire Localization: Both RFID and the standard of care wire localization will be performed for physician training.	RFID Localization n=15 Participants Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. RFID Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.	Wire Localization n=12 Participants Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). They will then be randomized to receive either the wire or RFID localization. There will be four visits: one pre-op breast surgery visit in which enrollment will occur, one radiology procedure visit for localization, one surgical visit, and one post-operative visit. This is the same number of visits as standard of care. Wire Localization: The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.
Number of Participants With Tumor Incompletely Excised	0 Participants	0 Participants	0 Participants

Adverse Events

RFID and Wire Localization

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RFID Localization

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wire 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

Megha Garg MD

University of Missouri

Phone: 573-882-1026

Email: gargmeg@health.missouri.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place