Clinical trial NCT03202472: Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery
Official title: Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Lesion
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2017-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography
timeFrame: at time of device placement, confirmed by mammography
measure: Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography
timeFrame: at time of surgery, within 30 days of tag implant
Secondary outcomes:
measure: Days Prior to Surgery of Insertion of Marker
timeFrame: Up to 30 days prior to surgery
measure: Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire
timeFrame: within 24 hours of device placement
measure: Patients With Cancer Requiring Re-excision
timeFrame: up to 4 weeks post initial surgery
measure: Patients With Documented Migration of Marker
timeFrame: at time of surgery, within 30 days of tag implant
measure: Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology
timeFrame: at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
measure: Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire
timeFrame: within 24 hours of device placement
measure: Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire
timeFrame: within 24 hours of surgery
measure: Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken)
timeFrame: at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Maggie DiNome, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DiNome ML, Kusske AM, Attai DJ, Fischer CP, Hoyt AC. Microchipping the breast: an effective new technology for localizing non-palpable breast lesions for surgery. Breast Cancer Res Treat. 2019 May;175(1):165-170. doi: 10.1007/s10549-019-05143-w. Epub 2019 Jan 28.