Breast Localization: RFID Tags vs Wire Localization
RFID
RFID Trial: Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire
1 other identifier
observational
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2021
CompletedFirst Posted
Study publicly available on registry
February 11, 2021
CompletedStudy Start
First participant enrolled
May 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2023
CompletedJune 18, 2023
June 1, 2023
1.9 years
February 8, 2021
June 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Satisfaction of surgeons and radiologists assessed by a questionnaire
1 years and 1 month
Evaluation of the quality of the RFID tag device by analizing surgery data
1 years and 1 month
Study Arms (2)
RFID tags localization
Wire localization
Interventions
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Multiple breast lesions
- Patients with breast neoplasia during pregnancy.
- Person deprived of liberty or under guardianship or incapable of giving consent
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Jean PERRIN
Clermont-Ferrand, 63011, France
Related Publications (2)
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: 39844175DERIVEDVeyssiere 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: 37468859DERIVED
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2021
First Posted
February 11, 2021
Study Start
May 15, 2021
Primary Completion
April 24, 2023
Study Completion
April 24, 2023
Last Updated
June 18, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share