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Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy
A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions
4 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2015
CompletedFirst Posted
Study publicly available on registry
May 1, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFebruary 2, 2017
January 1, 2017
9 months
April 28, 2015
January 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Feedback solicited from the radiologist and surgeon
Up to 12 months after lumpectomy
Study Arms (1)
Diagnostic (radiofrequency-guided localization)
EXPERIMENTALPatients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.
Interventions
Undergo lumpectomy
Undergo radiofrequency-guided localization
Eligibility Criteria
You may qualify if:
- 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
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Cancer Institute (NCI)collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jafi Lipson
Stanford University Hospitals and Clinics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2015
First Posted
May 1, 2015
Study Start
May 1, 2015
Primary Completion
February 1, 2016
Study Completion
May 1, 2016
Last Updated
February 2, 2017
Record last verified: 2017-01