Breast Neoplasm
Conditions
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.
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.
Interventions
PROCEDURELumpectomy
Undergo lumpectomy
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURERadiofrequency-Guided Localization
Undergo radiofrequency-guided localization
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Localization success, defined as the surgical target visualized in the removed specimen AND the RFID tag removed from the patient's breast | At time of surgery | Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feedback solicited from the radiologist and surgeon | 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. |
Outcome results
None listed