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OpenTrials
Completed

NCT Number: NCT04750889

Breast Localization: RFID Tags vs Wire Localization

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Jean PERRIN

Clermont-Ferrand, 63011, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RFID tags

Device

Installation of the RFID tag device wire localization)

Wire Localization

Device

Installation of the wire localization device

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

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

Acronym: RFID

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2021
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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