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

Jonsson Comprehensive Cancer Center

Status: Completed

Conditions: Breast Neoplasm; Lesion

Treatments: Procedure: Mammography; Procedure: Radiofrequency (RFID) -Guided Localization; Other: Questionnaire Administration; Procedure: Ultrasonography; Device: Implanted Medical Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03202472

17-000668 (Other Identifier)

NCI-2017-01097 (Registry Identifier)

UCLA LOCalizer 00 I

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of utilizing a new Federal Drug Administration (FDA)-cleared radiofrequency tag for localization of non-palpable breast lesions and provide preliminary data for a larger study.

OUTLINE:

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.

After completion of study, patients are followed up within 2 weeks.

Enrollment: 50 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to give written informed consent to participate in the study
• Able to read and write English
• Patients with breast lesions that are non-palpable that require surgical removal
• Lesions and/or clip targetable with image guidance

Exclusion criteria

• Multicentric breast cancer
• Stage IV breast cancer
• Pregnant or lactating females

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Diagnostic (radiofrequency-guided localization)

Experimental group

Description:

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.

Treatment:

Device: Implanted Medical Device

Procedure: Ultrasonography

Other: Questionnaire Administration

Procedure: Mammography

Procedure: Radiofrequency (RFID) -Guided Localization