Clinical trial NCT03684408: Radiofrequency Chip for Localization of Non-Palpable Breast Lesions
Official title: Use of a Radiofrequency Chip for Localization of Non-Palpable Breast Lesions: A Comparison to Wire Localization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Tumor
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Health Beacons
First posted: 2018-09-25
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Successful Localization
timeFrame: From the date of localization through the date of surgery up to 4 weeks; data collected during Visit 3 at time of surgery
Secondary outcomes:
measure: Surveys of Satisfaction: Participant
timeFrame: Data collected during date of localization at Visit 2, up to approximately one month from baseline visit
measure: Surveys of Satisfaction
timeFrame: Data collected at baseline during Visit 1
measure: Surveys of Satisfaction
timeFrame: Data collected during date of localization at Visit 2, up to approximately one month from baseline visit
measure: Number of Participants With Tumor Incompletely Excised
timeFrame: Surgical resection specimen collected during Visit 3, at time of surgery
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Megha Garg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dauphine C, Reicher JJ, Reicher MA, Gondusky C, Khalkhali I, Kim M. A prospective clinical study to evaluate the safety and performance of wireless localization of nonpalpable breast lesions using radiofrequency identification technology. AJR Am J Roentgenol. 2015 Jun;204(6):W720-3. doi: 10.2214/AJR.14.13201.
citation: Reicher JJ, Reicher MA, Thomas M, Petcavich R. Radiofrequency identification tags for preoperative tumor localization: proof of concept. AJR Am J Roentgenol. 2008 Nov;191(5):1359-65. doi: 10.2214/AJR.08.1023.