Breast Localization: RFID Tags vs Wire Localization

NCT04750889 — Completed, 80 participants, Centre Jean Perrin

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

RegistryNCT04750889, acronym RFID
StatusCompleted
Study typeObservational
Enrollment80 (Actual)
SponsorCentre Jean Perrin (Other)
ConditionsBreast Neoplasm Female
InterventionsRFID tags, Wire localization (Device)
Datesstart 2021-05-15, primary completion 2023-04-24, completion 2023-04-24, first posted 2021-02-11, last updated 2023-06-18
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Breast Neoplasm Female All trials of RFID tags All trials of Wire localization

-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 LOCalizerâ„¢ device compared to the gold standard device.

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+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.

+Arms and interventions

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

+Outcome measures

Primary outcomes

  • 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 outcomes

  • Satisfaction of surgeons and radiologists assessed by a questionnaire [1 years and 1 month]: overall score values from the surgeon and radiologist questionnaires
  • 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

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Centre Jean PERRINClermont-FerrandFrance

+Publications

  • Results publication: Pete R, Pinard C, Sirodot F, Molnar I, Dressaire M, Ginzac A, Abrial C, Durando X, Tekath M. Patient satisfaction with radio-frequency identification (RFID) tag localization compared with wire localization for nonpalpable breast lesions: the RFID trial. BMC Cancer. 2025 Jan 22;25(1):123. doi: 10.1186/s12885-025-13453-0. PMID 39844175
  • Results publication: Veyssiere H, Dressaire M, Pete R, Pinard C, Molnar I, Abrial C, Ginzac A, Durando X, Tekath M. RFID trial: localization of non-palpable breast lesions using radiofrequency identification tags or wire. BMC Cancer. 2023 Jul 20;23(1):679. doi: 10.1186/s12885-023-11190-w. PMID 37468859