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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03684408
Other study ID # 2011684
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 18, 2018
Est. completion date April 19, 2021

Study information

Verified date August 2022
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date April 19, 2021
Est. primary completion date April 19, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Missouri Columbia Missouri

Sponsors (2)

Lead Sponsor Collaborator
University of Missouri-Columbia Health Beacons

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Surveys of Satisfaction: Participant Survey Question: "Compared to expected, how uncomfortable was the localization?"
Scored on a scale of 1 to 5 with the best being 5
Data collected during date of localization at Visit 2, up to approximately one month from baseline visit
Secondary Surveys of Satisfaction Surveys of Radiology Nurse ease of scheduling the localization procedure.
Scored on a scale of 1 to 5 with the best being 5
Data collected at baseline during Visit 1
Secondary Surveys of Satisfaction Surveys of radiologist satisfaction with the localization procedure.
Scored on a scale of 1 to 5 with the best being 5
Data collected during date of localization at Visit 2, up to approximately one month from baseline visit
Secondary Number of Participants With Tumor Incompletely Excised Number of participants with positive margin on pathology Surgical resection specimen collected during Visit 3, at time of surgery
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