NCT03202472|CompletedResultsFDA Device

Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery

Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery

Jonsson Comprehensive Cancer Center ClinicalTrials.gov

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3 other identifiers

17-000668NCI-2017-01097UCLA LOCalizer 00 I

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJun 2017

StartedAug 2017

CompletionFeb 2019

Brief Summary

This pilot clinical trial studies radiofrequency technology in locating non-palpable breast lesions in patients undergoing surgery. Placing a miniature radiofrequency tag or microchip in the breast lesion before surgery and using a handheld device to guide doctors during surgery may improve surgical outcomes in patients with non-palpable breast lesions.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Aug 2017

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

June 26, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed

1 month until next milestone

Study Start

First participant enrolled

August 3, 2017

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2018

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

July 7, 2020

Completed

Last Updated

July 24, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 26, 2017

Results QC Date

May 28, 2020

Last Update Submit

July 22, 2020

Conditions

Breast Neoplasm Lesion

Outcome Measures

Primary Outcomes (2)

Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography
Patients with successful radiofrequency tag placement
at time of device placement, confirmed by mammography
Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography
Patients with successful radiofrequency tag retrieval.
at time of surgery, within 30 days of tag implant

Secondary Outcomes (8)

Days Prior to Surgery of Insertion of Marker
Up to 30 days prior to surgery
Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire
within 24 hours of device placement
Patients With Cancer Requiring Re-excision
up to 4 weeks post initial surgery
Patients With Documented Migration of Marker
at time of surgery, within 30 days of tag implant
Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology
at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
+3 more secondary outcomes

Study Arms (1)

Diagnostic (radiofrequency-guided localization)

EXPERIMENTAL

Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery.

Device: Implanted Medical DeviceProcedure: MammographyOther: Questionnaire AdministrationProcedure: Radiofrequency (RFID) -Guided LocalizationProcedure: Ultrasonography