Breast Localization: RFID Tags vs Wire Localization

Completed

• Conditions: Breast Neoplasm Female
• Interventions: Device: RFID tags; Device: Wire localization

• Registration Number: NCT04750889
• Lead Sponsor: Centre Jean Perrin

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.

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-11
• Study Start: 2021-05-15
• Primary Completion: 2023-04-24
• Study Completion: 2023-04-24
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RFID tags localization	RFID tags	-
Wire localization	Wire localization	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the patients satisfaction	1 years and 1 month	The value of the satisfaction score of the patient questionnaire from 0 (worst statisfaction) to 10 (better statisfaction)

Secondary Outcome Measures

Name	Time	Method
Evaluation of the quality of the RFID tag device by analizing surgery data	1 years and 1 month	the occurrence or not of a migration of the RFID tag, histological data, the invasion of the margins and the rate of reoperation
Satisfaction of surgeons and radiologists assessed by a questionnaire	1 years and 1 month	overall score values from the surgeon and radiologist questionnaires

Trial Locations

Locations (1)

Centre Jean PERRIN; 🇫🇷 Clermont-Ferrand, France