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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
Sunita Pal

Clinical Associate Professor, Radiology

Debra M. Ikeda, M.D.
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