Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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 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.

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.

RFID Localization

Wire Localization

Both RFID and the standard of care wire localization will be performed for physician training.

RFID and Wire Localization

Megha Garg, MD

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.

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.

Radiofrequency Chip for Localization of Non-Palpable Breast Lesions

Use of a Radiofrequency Chip for Localization of Non-Palpable Breast Lesions: A Comparison to Wire Localization

Whether the surgeon was able to identify and remove the tumor

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 Radiology Nurse ease of scheduling the localization procedure.

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

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 positive margin on pathology

Health Beacons

University of Missouri-Columbia

Associate Professor of Clinical Radiology

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.

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.

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

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Megha Garg MD

Number of Participants With Successful Localization

Surveys of Satisfaction: Participant

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 Satisfaction

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.

Spots Global Cancer Trial Database for rfid localization