NCT02432118

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

A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Lumpectomy	Undergo lumpectomy
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Radiofrequency-Guided Localization	Undergo radiofrequency-guided localization

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-02-01
• Completion: 2016-05-01
• First posted: 2015-05-01
• Last updated: 2017-02-02