Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy

Stanford University

Status: Withdrawn

Conditions: Breast Neoplasm

Treatments: Procedure: Radiofrequency-Guided Localization; Other: Questionnaire Administration; Procedure: Lumpectomy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02432118

P30CA124435 (U.S. NIH Grant/Contract)

BRS0053 (Other Identifier)

NCI-2015-00630 (Registry Identifier)

348

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Diagnostic (radiofrequency-guided localization)

Experimental group

Description:

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

Treatment:

Procedure: Lumpectomy

Other: Questionnaire Administration

Procedure: Radiofrequency-Guided Localization