Radiofrequency Chip for Localization of Non-Palpable Breast Lesions

University of Missouri (MU)

Status: Completed

Conditions: Breast Tumor

Treatments: Device: RFID and Wire Localization; Device: Wire Localization; Device: RFID Localization

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03684408

2011684

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

RFID and Wire Localization

Other group

Description:

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.

Treatment:

Device: RFID and Wire Localization

RFID Localization

Experimental group

Description:

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.

Treatment:

Device: RFID Localization

Wire Localization

Active Comparator group

Description:

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.

Treatment:

Device: Wire Localization