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.
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.
Study Type
OBSERVATIONAL
Enrollment
772
magnetic clip localization for preoperative localization for breast cancer surgery
metallic wire localization for preoperative localization for 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
Hospices Civils de Lyon Hopital de la Croix rousse
Lyon, France
RECRUITINGCentre Léon Bérard
Lyon, France
RECRUITINGInstitut de Cancérologie de Lorraine (ICL)
Nancy, France
RECRUITINGHôpital Nord -Ouest Val d'Oise (NOVO)
Pontoise, France
RECRUITINGInstitut GODINOT
Reims, France
RECRUITINGCentre Eugène Marquis
Rennes, France
NOT_YET_RECRUITINGInstitut Gustave Roussy
Villejuif, France
RECRUITINGComparison of the average total cost of patient care with magnetic clip localization versus the use of a hookwire, up to 6 months post-surgery
Effectiveness of localization in terms of lesion identification (did the localization, based on the pathological report, allow the lesion to be located in the breast?) * Rate of clear margins (for isolated in situ lesions: margin ≥ 2 mm, and for invasive cancers: non-zero margin) * Percentage of patients requiring re-intervention due to an unclear margin * Measured distance between the marker and the target lesion during the procedure * Ratio between the weight of the resected specimen and the lesion size in g/mm² * Patient satisfaction with their care, assessed using a 5-point Likert scale during the postoperative consultation (between day 15 and day 30 after resection) * Radiologist satisfaction with the marker placement, assessed using a 5-point Likert scale immediately after placement * Surgeon satisfaction with lesion localization, assessed using a 5-point Likert scale at the end of the surgery.
Time frame: 6 months post surgery
Quality of life of patientes
Quality of life assessed using the 5-level EQ-5D version (EQ-5D-5L).The questionnaire assesses 5 dimensions (Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression). Each dimension is rated on 5 levels (from 1 = no problems to 5 = extreme problems).
Time frame: At inclusion, 15 to 30 days after surgery and 6 months after surgery
Satisfaction of radiologist and surgeon
Questionnaire to evaluate the satisfaction of radiologist after the maker placement and questionnaire to evaluate the satisfaction of surgeon after the surgery. The score isn't on a scale.
Time frame: Within 24 hours after the maker placement and within 24 hours after the surgery
Patient satisfaction and experience.
Questionnaire after the surgery to evaluated the patient satisfaction and experience. The score isn't on a scale.
Time frame: 15 to 30 days after surgery
Budget impact analysis of pre operative magnetic clip localization versus the use of a hookwire.
The decision to include a Budget Impact Analysis (BIA) in this study is in line with the framework agreement signed in January 2016 between the Economic Committee for Medicinal Products (Comité Economique des Produits de Santé - CEPS, in French) and the Pharmaceutical Industry (Les Entreprises du Médicament - LEEM, in French), which advises the implementation of a BIA in addition to the medico-economic study. The BIA will strictly comply with the HAS requirements presented in its methodological guide for BIA. A budget impact model (BIM) will be developed with the French National health insurance perspective. The cost of the current (hookwire) or new intervention (magnetic clip) mix will be assessed. The population to be included in a BIA will be all patients eligible in France for the new intervention during the time horizon of 3 years. The results will be expressed in incremental budget impact in the first, second and third year.
Time frame: At 1, 2 and 3 years
The organisationnal impact of magnetic clip versus metallic wires.
The organizational analysis will be based on performance indicators of magnetic clips compared to metallic wires, such as the number of patient visits to the hospital before surgery, the number of localization procedures performed on the day of the intervention, the length of stay, waiting times, and the number of emergency visits throughout the follow-up period. The stochastic variables (lengths of stay, intervals between stays) will be modeled using appropriate statistical distributions, determined by maximum likelihood estimation based on statistical analyses of the extracted data.
Time frame: At 6 months
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