RecruitingNCT06906601

Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.

Sponsor

Centre Leon Berard

Enrollment

772 participants

Start Date

Apr 15, 2025

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Breast Cancer Surgery Medico-economic Impact

Summary

MAGNETO is a French medico-economic study on preoperative localization in breast cancer surgery. The main objective is to conduct a cost-consequence analysis comparing magnetic clip localization with the use of metallic wires for the preoperative identification of non-palpable breast lesions. The choice of localization method is left to the physician's and center's discretion. The study is non-interventional (with only questionnaires and data collection), prospective, and multicenter, with patient follow-up lasting up to six months after breast surgery.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

I1. Female aged ≥ 18 years;
I2. Patient presenting with a unifocal and unilateral lesion of invasive carcinoma or in situ;
I3. Indication for first breast-conserving treatment with the need for preoperative localization of the lesion, regardless of the associated lymph node procedure;
I4. Patient affiliated with a health insurance system;
I5. Non-opposition to the study.

Exclusion Criteria7

E.1. Psychological, family, or sociological condition that may potentially compromise adherence to the treatment protocol and follow-up;
E.2. Bilateral surgery required;
E.3. Patient with metastatic breast cancer;
E.4. Multifocal or benign lesions;
E.5. Pregnant or breastfeeding patient;
E.6. Need for neoadjuvant treatment;
E.8. Patient under guardianship, curatorship, or deprived of liberty.

Interventions

PROCEDUREmagnetic clip localization

magnetic clip localization for preoperative localization for breast cancer surgery

PROCEDUREmetallic wire localization.

metallic wire localization for preoperative localization for breast cancer surgery

PROCEDUREBreast cancer surgery

Patient with invasive or in situ breast carcinoma, presenting with a unifocal and unilateral lesion, requiring a first-line breast-conserving treatment with preoperative localization, regardless of the associated lymph node procedure