Radiofrequency Chip for Localization of Non-Palpable Breast Lesions

NCT03684408 | Completed Results FDA Device

• 1 other identifier: 2011684
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Tumor

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Localization

  Whether the surgeon was able to identify and remove the tumor

  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 (4)

• Surveys of Satisfaction: Participant

  Data collected during date of localization at Visit 2, up to approximately one month from baseline visit

• Surveys of Satisfaction

  Data collected at baseline during Visit 1

• Surveys of Satisfaction

  Data collected during date of localization at Visit 2, up to approximately one month from baseline visit

• Number of Participants With Tumor Incompletely Excised

  Surgical resection specimen collected during Visit 3, at time of surgery

Study Arms (3)

RFID and Wire Localization

OTHER

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.

Device: RFID and Wire Localization

RFID Localization

EXPERIMENTAL

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.

Device: RFID Localization

Wire Localization

ACTIVE COMPARATOR

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.

Device: Wire Localization

Interventions

RFID Localization DEVICE

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 DEVICE

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.

Wire Localization

RFID and Wire Localization DEVICE

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

RFID and Wire Localization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women requiring image guided pre-operative breast tumor localization

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Health Beacons: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (2)

• 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.

  PMID: 26001262 BACKGROUND

• 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.

  PMID: 18941069 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radio Frequency Identification Device

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Patient Identification Systems; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Megha Garg MD
• Organization: University of Missouri

gargmeg@health.missouri.edu

573-882-1026

Study Officials

• Megha Garg, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Radiology

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: September 25, 2018
• Study Start: October 18, 2018
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: August 25, 2022
• Results First Posted: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)