Breast Neoplasm FemaleRFIDNCT04750889
Breast Localization: RFID Tags vs Wire Localization
An observational study of Breast Neoplasm Female, run by Centre Jean Perrin at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- RFID tags and Wire localization
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2021to 24 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Multiple breast lesions
- Patients with breast neoplasia during pregnancy.
- Person deprived of liberty or under guardianship or incapable of giving consent
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Neoplasm Female
- Being tested
- RFID tags, Wire localization
- Keywords
- Non palpable breast cancer, RFID tags, Observational study, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFID tagsDevice
Installation of the RFID tag device wire localization)
Wire localizationDevice
Installation of the wire localization device
| Study group | Role | What they receive |
|---|---|---|
| RFID tags localization | Not described Receives: Device: RFID tags | |
| Wire localization | Not described Receives: Device: Wire localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the patients satisfaction
The value of the satisfaction score of the patient questionnaire from 0 (worst statisfaction) to 10 (better statisfaction)
Measured: 1 years and 1 month
Secondary outcomes (2)
Satisfaction of surgeons and radiologists assessed by a questionnaire
overall score values from the surgeon and radiologist questionnaires
Measured: 1 years and 1 month
Evaluation of the quality of the RFID tag device by analizing surgery data
the occurrence or not of a migration of the RFID tag, histological data, the invasion of the margins and the rate of reoperation
Measured: 1 years and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start15 May 2021
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750889
- Sponsor's protocol ID
- RFID
- Acronym
- RFID
- Status last verified
- Jun 2023
- First submitted
- 8 Feb 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39844175Veyssiere 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.
PubMed 37468859
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RFID Trial: Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire
- ClinicalTrials.gov ID
- NCT04750889
- Acronym / sponsor ID
- RFID / RFID
- Conditions
- Breast Neoplasm Female
- Keywords
- Non palpable breast cancer, RFID tags, Observational study, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFID tags localization | – | Device: RFID tags |
| Wire localization | – | Device: Wire localization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Multiple breast lesions
- Patients with breast neoplasia during pregnancy.
- Person deprived of liberty or under guardianship or incapable of giving consent
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFID tagsInstallation of the RFID tag device wire localization) | Device | RFID tags localization |
| Wire localizationInstallation of the wire localization device | Device | Wire localization |
Primary outcome
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)
2 secondary outcomes
Satisfaction of surgeons and radiologists assessed by a questionnaire
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 39844175Pete 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.
- Derived from this study: PubMed 37468859Veyssiere 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm Female, run by Centre Jean Perrin at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the patients satisfaction (time frame: 1 years and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04750889, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023; AzTrials last refreshed its copy on 1 Nov 2026.