Radiofrequency Chip for Localization of Non-Palpable Breast Lesions

Not Applicable

Completed

Conditions: Breast Tumor

Interventions: Device: RFID and Wire Localization
Device: Wire Localization
Device: RFID Localization

Registration Number: NCT03684408

Lead Sponsor: University of Missouri-Columbia

Brief Summary: The purpose of the project is to compare Radiofrequency identification device (RFID) localization technique with the current clinical standard wire localization technique. The Investigator's hypotheses is that the RFID localization technique is non-inferior to wire localization for breast lesions (tumors).

The study will be conducted in two parts. The purpose of Part A is for physician training with the RFID device. Nine subjects will undergo RFID and wire localization prior to breast lesion excision. This will allow the breast radiologists and surgeons to become comfortable with RFID device placement and retrieval. Additionally, the investigators will pilot the data collection surveys and chart review methodology to be used in Part B.

The purpose of Part B is to conduct a randomized clinical trial to assess whether RFID localization is non-inferior to wire localization for breast lesions. For this part, sixty subjects will be randomized to RFID (N=30) or wire localization (N=30) at time of enrollment. Surveys will be used to gather data from participants, radiologists, surgeons, and technologists/mammography nurses. A variety of data will be collected including, but not limited to, information on tumor size, location, depth; subject demographics; adequacy of tumor margins, re-excision rates, accuracy of wire or chip placement, and surgical complications.

Detailed Description: As part of standard of care, participants will receive: an ultrasound (US) or mammographic guided localization; excisional breast surgery; and a follow-up visit in breast surgery clinic.

As part of the research protocol, participants will receive a RFID chip for the localization procedure and complete surveys.

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. Participants, radiologists, surgeons, breast surgery and radiology staff will complete surveys.

Part B of this project is a prospective trial to examine safety, efficacy, operating room utilization patterns, and satisfaction with RFID versus wire localization. Participants will be stratified based on technique of localization (either US guidance or mammographic guidance). Participants 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. Participants, radiologists, surgeons, breast surgery and radiology staff will complete surveys.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 38

Inclusion Criteria

Women requiring image guided pre-operative breast tumor localization

Exclusion Criteria

Tumors deeper than 6 cm from the skin surface
More than one tumor requiring localization
Tumors requiring bracketing
Tumors requiring Magnetic Resonance Imaging localization
Inability to complete survey
Pregnancy

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFID and Wire Localization	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.
Wire Localization	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.
RFID Localization	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Successful Localization	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

Secondary Outcome Measures

Name	Time	Method
Surveys of Satisfaction: Participant	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
Surveys of Satisfaction	Data collected during date of localization at Visit 2, up to approximately one month from baseline visit	Surveys of radiologist satisfaction with the localization procedure. Scored on a scale of 1 to 5 with the best being 5
Number of Participants With Tumor Incompletely Excised	Surgical resection specimen collected during Visit 3, at time of surgery	Number of participants with positive margin on pathology