Breast Localization: RFID Tags vs Wire Localization

NCT ID: NCT04750889

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-15

Study Completion Date

2023-04-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasm Female

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RFID tags localization

RFID tags

Intervention Type DEVICE

Installation of the RFID tag device wire localization)

Wire localization

Wire localization

Intervention Type DEVICE

Installation of the wire localization device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RFID tags

Installation of the RFID tag device wire localization)

Intervention Type DEVICE

Wire localization

Installation of the wire localization device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Jean Perrin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Jean PERRIN

Clermont-Ferrand, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39844175 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37468859 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RFID

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Locoregional Recurrence of Breast Cancer
NCT05988112 NOT_YET_RECRUITING
Elevate! : An Elderly Breast Cancer Cohort Study
NCT03818087 ACTIVE_NOT_RECRUITING