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Radiofrequency-Guided Localization in Patients With Abnormal Breast Tissue Undergoing Lumpectomy
Not Recruiting
Trial ID: NCT02432118
Purpose
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.
Official Title
A Feasibility Study of Radiofrequency Identification (RFID) Localization of Breast Lesions
Stanford Investigator(s)
Sunita Pal
Clinical Associate Professor, Radiology
Debra M. Ikeda, M.D.
Professor of Radiology (Breast Imaging), Emerita
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
Intervention(s):
procedure: Lumpectomy
other: Questionnaire Administration
procedure: Radiofrequency-Guided Localization
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sumita Sood
650-723-0186