Radiofrequency Chip for Localization of Non-Palpable Breast Lesions
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/25/2018 |
| Start Date: | October 18, 2018 |
| End Date: | December 31, 2020 |
| Contact: | Joanne Cassani, RN, CCRC |
| Email: | cassanij@health.missouri.edu |
| Phone: | 573-882-3677 |
Use of a Radiofrequency Chip for Localization of Non-Palpable Breast Lesions: A Comparison to Wire Localization
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.
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.
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.
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.
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
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