N/A
Completed N=50
Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery
Breast Neoplasm · Lesion
Source: ClinicalTrials.gov NCT03202472 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography — 50 Participants
Summary
This pilot clinical trial studies radiofrequency technology in locating non-palpable breast lesions in patients undergoing surgery. Placing a miniature radiofrequency tag or microchip in the breast lesion before surgery and using a handheld device to guide doctors during surgery may improve surgical outcomes in patients with non-palpable breast lesions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography |
50 | — |
| PRIMARY Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography |
50 | — |
| SECONDARY Days Prior to Surgery of Insertion of Marker |
1.4 | — |
| SECONDARY Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire |
21.3 | — |
| SECONDARY Patients With Cancer Requiring Re-excision |
2 | — |
| SECONDARY Patients With Documented Migration of Marker |
— | — |
| SECONDARY Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology |
4 | — |
| SECONDARY Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire |
20.4 | — |
| SECONDARY Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire |
21.5 | — |
| SECONDARY Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken) |
30.7 | — |
Eligibility Criteria
Inclusion Criteria
- Able to give written informed consent to participate in the study
- Able to read and write English
- Patients with breast lesions that are non-palpable that require surgical removal
- Lesions and/or clip targetable with image guidance
Exclusion Criteria
- Multicentric breast cancer
- Stage IV breast cancer
- Pregnant or lactating females
Data sourced from ClinicalTrials.gov (NCT03202472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.