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

Breast Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02432118
• Other study ID #: BRS0053
• Secondary ID: NCI-2015-0063034
• Status: Withdrawn
• Phase: N/A
• First received: April 28, 2015
• Last updated: January 31, 2017
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Procedure:
• Lumpectomy
Undergo lumpectomy

Other:
• Questionnaire Administration
Ancillary studies

Procedure:
• Radiofrequency-Guided Localization
Undergo radiofrequency-guided localization

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast	Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions.	At time of surgery
Secondary	Feedback solicited from the radiologist and surgeon	Feedback solicited from the radiologist and surgeon will be summarized using qualitative methods. Each questionnaire will be reviewed for both positive and negative responses and summarized.	Up to 12 months after lumpectomy