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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00630 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 348 | |||
| BRS0053 | Other Identifier | Stanford University Hospitals and Clinics | |
| P30CA124435 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (radiofrequency-guided localization) | Experimental | Patients undergo radiofrequency-guided localization comprising RFID tag placement before lumpectomy and interactive detection of tag using RFID reader during lumpectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumpectomy | Procedure | Undergo lumpectomy |
|
| 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 | Will be summarized using descriptive statistics, including total numbers, percentages, means, and proportions. | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Feedback solicited from the radiologist and surgeon | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jafi Lipson | Stanford University Hospitals and Clinics | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015412 | Mastectomy, Segmental |
| D057233 | Radio Frequency Identification Device |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
| D004864 | Equipment and Supplies |
| D010355 | Patient Identification Systems |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Radiofrequency-Guided Localization | Procedure | Undergo radiofrequency-guided localization |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |