Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: magnetic clip localization, metallic wire localization., Breast cancer surgery.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Medico-economic Impact, Breast Cancer Surgery. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
The MAGNETO study is a non-interventional, prospective, and multicenter study. It includes two cohorts: one using magnetic clip localization and the other using metallic wire localization.
Patients are enrolled by the surgeon during the preoperative consultation validating the conservative surgery with preoperative localization. The choice of cohort is left to the discretion of the center based on their routine practice. Baseline data, including patient and disease characteristics, are collected.
Depending on the assigned cohort, localization is performed either with a magnetic clip or a metallic wire. A mammogram is then performed to assess the correct positioning of the marker and its distance from the target lesion. At this stage, the radiologist completes a Likert scale satisfaction questionnaire.
Breast-conserving surgery is performed according to the hospital's standard practices. On the day of the procedure, the surgeon also completes a Likert scale satisfaction questionnaire.
Patients complete quality of life (EQ-5D-5L) and satisfaction questionnaires at several points throughout the study. Postoperative complications are also recorded.
Interventions
- Procedure magnetic clip localization
magnetic clip localization for preoperative localization for breast cancer surgery - Procedure metallic wire localization.
metallic wire localization for preoperative localization for breast cancer surgery - Procedure Breast 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
Primary outcome measures
- Comparison of the average total cost of patient care with magnetic clip localization versus the use of a hookwire, up to 6 months post-surgery [Time frame: 6 months post surgery]
Secondary outcome measures (5)
- Quality of life of patientes [Time frame: At inclusion, 15 to 30 days after surgery and 6 months after surgery]
- Satisfaction of radiologist and surgeon [Time frame: Within 24 hours after the maker placement and within 24 hours after the surgery]
- Patient satisfaction and experience. [Time frame: 15 to 30 days after surgery]
- Budget impact analysis of pre operative magnetic clip localization versus the use of a hookwire. [Time frame: At 1, 2 and 3 years]
- The organisationnal impact of magnetic clip versus metallic wires. [Time frame: At 6 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 7 centers
- Hospices Civils de Lyon Hopital de la Croix rousse — Lyon
- Centre Léon Bérard — Lyon
- Institut de Cancérologie de Lorraine (ICL) — Nancy
- Hôpital Nord -Ouest Val d'Oise (NOVO) — Pontoise
- Institut GODINOT — Reims
- Centre Eugène Marquis — Rennes
- Institut Gustave Roussy — Villejuif
Identifiers
NCT: NCT06906601 · ET24-213 (MAGNETO)