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The RFID trial focuses on breast localization in patients with non-palpable breast cancers. It aims to demonstrate the improvement in patient comfort when using the Radio Frequency Identification (RFID) tag and LOCalizerâ„¢ device compared to the gold standard device.
It is an observational, prospective, single-center, 2-arm (RFID group vs. standard gold), non-randomized and category 3 comparative study. The RFID trial focuses on breast localization in patients with non-palpable breast cancers. These patients will benefit from a mastology consultation: consent will then be acquired. The RFID tag or the gold standard localization will be put in place during this consultation (one day before surgery).
Patients will fill in their questionnaire in two steps:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFID tags localization |
| ||
| Wire localization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RFID tags | Device | Installation of the RFID tag device wire localization) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the patients satisfaction | The value of the satisfaction score of the patient questionnaire from 0 (worst statisfaction) to 10 (better statisfaction) | 1 years and 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of surgeons and radiologists assessed by a questionnaire | overall score values from the surgeon and radiologist questionnaires | 1 years and 1 month |
| Evaluation of the quality of the RFID tag device by analizing surgery data |
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Inclusion Criteria:
Exclusion Criteria:
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18 years of age or older patients requiring conservative surgical management for a breast lesion infra-clinical (fibroadenomas, papillomas, atypical lesions, neoplasia), whose histology will have been proven beforehand by anatomopathology
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean PERRIN | Clermont-Ferrand | 63011 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39844175 | Derived | Pete R, Pinard C, Sirodot F, Molnar I, Dressaire M, Ginzac A, Abrial C, Durando X, Tekath M. Patient satisfaction with radio-frequency identification (RFID) tag localization compared with wire localization for nonpalpable breast lesions: the RFID trial. BMC Cancer. 2025 Jan 22;25(1):123. doi: 10.1186/s12885-025-13453-0. | |
| 37468859 |
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| Wire localization |
| Device |
Installation of the wire localization device |
|
the occurrence or not of a migration of the RFID tag, histological data, the invasion of the margins and the rate of reoperation
| 1 years and 1 month |
| Veyssiere H, Dressaire M, Pete R, Pinard C, Molnar I, Abrial C, Ginzac A, Durando X, Tekath M. RFID trial: localization of non-palpable breast lesions using radiofrequency identification tags or wire. BMC Cancer. 2023 Jul 20;23(1):679. doi: 10.1186/s12885-023-11190-w. |