Breast Localization: RFID Tags vs Wire Localization

Breast Neoplasm Female Clinical Trial

— RFID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750889
• Other study ID #: RFID
• Status: Completed
• Start date: May 15, 2021
• Est. completion date: April 24, 2023

Study information

• Verified date: June 2023
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms

Intervention

Device:
• RFID tags
Installation of the RFID tag device wire localization)
• Wire localization
Installation of the wire localization device

Locations

Country	Name	City	State
France	Centre Jean PERRIN	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Satisfaction of surgeons and radiologists assessed by a questionnaire	overall score values from the surgeon and radiologist questionnaires	1 years and 1 month
Secondary	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