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

Trial ID or NCT#

NCT02432118

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Sunita Pal
Sunita Pal
Radiologist, Interventional radiologist
Clinical Associate Professor, Radiology
Debra M. Ikeda, M.D.
Debra M. Ikeda, M.D.
Radiologist
Professor of Radiology (Breast Imaging), Emerita

Contact us to find out if this trial is right for you.

Contact

Sumita Sood
650-723-0186