Clinical trial NCT02432118: Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy
Official title: A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Neoplasm
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-05-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
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 the use of the radiofrequency-guided localization in patients with abnormal breast tissue undergoing lumpectomy (a type of breast-sparing surgery). The radiofrequency identification localization system consists of an implantable radiofrequency identification tag and a hand-held radiofrequency reader to mark abnormal breast tissue before surgery and later surgically retrieve them. Radiofrequency-guided localization may make it easier to find and remove abnormal breast tissue during lumpectomy.

Detailed description: PRIMARY OBJECTIVES:

I. To obtain human clinical data in order to demonstrate that the Radiofrequency Identification (RFID) Localization System performs as intended as a localization device for marking and retrieving a surgical target in the breast.

SECONDARY OBJECTIVES:

I. To solicit feedback from the radiologists and surgeons regarding the process and use of the RFID system.

OUTLINE:

Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.

Eligibility criteria: Inclusion Criteria:

* Have had stereotactic or ultrasound-guided biopsy with marker placement
* Have a lesion or biopsy marker that is visible under ultrasound
* Have a surgical target =\< 6 cm from the skin when lying supine
* Have a discreet surgical target
* Have a lesion in which the center/focal area is defined
* Have the ability to understand and the willingness to sign a written informed consent document
* Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an inclusion criterion
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Require more than one localization needle for localization of the surgical target (bracket localization)
* Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast
* Have a prosthesis/implant in the operative breast
* Have a cardiac pacemaker or defibrillator device
* Be contraindicated for surgery
* Be pregnant

Primary outcomes:
measure: Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast
timeFrame: At time of surgery
Secondary outcomes:
measure: Feedback solicited from the radiologist and surgeon
timeFrame: Up to 12 months after lumpectomy
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University Hospitals and Clinics
name: Jafi Lipson
role: PRINCIPAL_INVESTIGATOR
References: