Breast Localization: RFID Tags vs Wire Localization (RFID)

June 16, 2023 updated by: Centre Jean Perrin

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

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RFID tags localization
Installation of the RFID tag device wire localization)
Wire localization
Installation of the wire localization device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the patients satisfaction
Time Frame: 1 years and 1 month
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
Time Frame: 1 years and 1 month
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
Time Frame: 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
1 years and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Actual)

April 24, 2023

Study Completion (Actual)

April 24, 2023

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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