Preoperative magnetic clip versus wire localization for breast-conserving surgery in France.
Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.
This project tests whether magnetic clips or traditional metal wires work better and cost less for women having breast-conserving surgery to locate a single, non-palpable breast cancer lesion.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 772 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Leon Berard Academic / other |
| Locations | 7 sites (Lyon and 6 other locations) |
| Trial ID | NCT06906601 on ClinicalTrials.gov |
What this trial studies
MAGNETO is a prospective, non-interventional, multicenter French study comparing two routine localization methods—magnetic clip and metallic wire—for non-palpable, unifocal breast lesions. Patients are enrolled at preoperative consultation and followed for up to six months after surgery, with baseline clinical data, quality-of-life (EQ-5D-5L), satisfaction questionnaires, and complication recording. Radiologists and surgeons complete Likert-scale satisfaction questionnaires after localization and on the day of surgery, and centers follow their usual clinical practices without assigned randomization. The primary analysis is a cost-consequence comparison between the two localization approaches using real-world practice patterns across participating centers.
Who should consider this trial
Good fit: Adult women (≥18 years) with a single, unilateral invasive or in situ breast lesion who are scheduled for first-time breast-conserving surgery and require preoperative localization are eligible.
Not a fit: Patients needing bilateral or multifocal surgery, those with metastatic disease, those requiring neoadjuvant therapy, pregnant or breastfeeding women, or those unable to comply with follow-up are unlikely to be represented or benefit from the results.
Why it matters
Potential benefit: If successful, magnetic clip localization could lower overall costs, improve scheduling flexibility, and increase patient and clinician satisfaction compared with wire localization.
How similar studies have performed: Previous clinical series and trials of magnetic seed/clip localization have demonstrated comparable targeting accuracy and logistical advantages over wires, though robust medico-economic comparisons in routine practice are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Lyon and 6 other locations
- Hospices Civils de Lyon Hopital de la Croix rousse — Lyon, France (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Institut de Cancérologie de Lorraine (ICL) — Nancy, France (Recruiting)
- Hôpital Nord -Ouest Val d'Oise (NOVO) — Pontoise, France (Recruiting)
- Institut GODINOT — Reims, France (Recruiting)
- Centre Eugène Marquis — Rennes, France (Not_yet_recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Severine Metzger
- Email: severine.metzger@lyon.unicancer.fr
- Phone: +33 (0)4 78 78 27 86
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.