Breast Localization: RFID Tags vs Wire Localization

Study Overview
=================
Brief Summary
-----------------
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 LOCalizer™ device compared to the gold standard device.

Detailed Description
-----------------
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: during the installation of the device (RFID tag or wire localization) to evaluate the patient's pain, then at the 1-month post-operative consultation to assess pain in the interval until surgery Radiologists and surgeons will fill out the questionnaire dedicated to them after each procedure.

Official Title
-----------------
RFID Trial: Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire

Conditions
-----------------
Breast Neoplasm Female

Intervention / Treatment
-----------------
* Device: RFID tags
* Device: Wire localization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older, Requiring conservative surgical management for a breast lesion -infra-clinical (fibroadenomas, papillomas, atypical lesions, neoplasia), whose histology will have been proven beforehand by anatomopathology. Patients referred to mastology for preoperative identification by the surgeons Able to give informed consent to participate in the research. Affiliation to a Social Security regime Exclusion Criteria: Multiple breast lesions Patients with breast neoplasia during pregnancy. Person deprived of liberty or under guardianship or incapable of giving consent Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RFID tags localization<br> | Device: RFID tags<br>* Installation of the RFID tag device wire localization)<br>|
| Wire localization<br> | Device: Wire localization<br>* Installation of the wire localization device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Non palpable breast cancer, RFID tags, Observational study