Breast Neoplasm Female
Conditions
Keywords
Non palpable breast cancer, RFID tags, Observational study, Surgery
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.
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.
Interventions
DEVICERFID tags
Installation of the RFID tag device wire localization)
DEVICEWire localization
Installation of the wire localization device
Sponsors
Centre Jean Perrin
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed