Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy
January 31, 2017 updated by: Stanford University
A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic (radiofrequency-guided localization)
Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy.
|
Ancillary studies
Undergo lumpectomy
Other Names:
Undergo radiofrequency-guided localization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast
Time Frame: At time of surgery
|
Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions.
|
At time of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feedback solicited from the radiologist and surgeon
Time Frame: Up to 12 months after lumpectomy
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jafi Lipson, Stanford University Hospitals and Clinics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Anticipated)
February 1, 2016
Study Completion (Anticipated)
May 1, 2016
Study Registration Dates
First Submitted
April 28, 2015
First Submitted That Met QC Criteria
April 28, 2015
First Posted (Estimate)
May 1, 2015
Study Record Updates
Last Update Posted (Estimate)
February 2, 2017
Last Update Submitted That Met QC Criteria
January 31, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRS0053 (Other Identifier: Stanford University Hospitals and Clinics)
- P30CA124435 (U.S. NIH Grant/Contract)
- 348
- NCI-2015-00630 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.