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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Cancer Surgery; Medico-economic Impact
• Intervention / Treatment: Procedure: magnetic clip localization; Procedure: Breast cancer surgery; Procedure: metallic wire localization.

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.

• Study Type: Observational
• Enrollment (Estimated): 772

Contacts and Locations

• Study Contact: Name: Severine Metzger; Phone Number: +33 (0)4 78 78 27 86; Email: severine.metzger@lyon.unicancer.fr
• Study Contact Backup: Name: Marie Osdoit, Dr; Email: Marie.OSDOIT@lyon.unicancer.fr

Study Locations

• France
  • Lyon, France, 69008
    • Recruiting
    • Centre Leon Berard
    • Contact: Marie OSDOIT, Dr; Phone Number: +33 (0)4 78 78 28 28; Email: Marie.OSDOIT@lyon.unicancer.fr
  • Lyon, France, 69004
    • Recruiting
    • Hospices Civils de Lyon Hopital de la Croix rousse
    • Contact: Marion CORTET, Dr; Phone Number: +33 (0)4 72 11 80 88; Email: marion.cortet@chu-lyon.fr
  • Nancy, France, 54519
    • Recruiting
    • Institut de Cancérologie de Lorraine (ICL)
    • Contact: David Manuel GOMES, Dr; Phone Number: +33 (0)3 83 59 84 00; Email: m.gomesdavid@nancy.unicancer.fr
  • Pontoise, France, 95300
    • Recruiting
    • Hôpital Nord -Ouest Val d'Oise (NOVO)
    • Contact: Sophie VAUTIER-RIT, Dr; Phone Number: +33 (0)1 30 75 40 40; Email: sophie.vautier-rit@ght-novo.fr
  • Reims, France, 51726
    • Recruiting
    • Institut Godinot
    • Contact: Judicaël HOTTON, Dr; Phone Number: +33 (0)3 26 50 44 44; Email: judicael.hotton@reims.unicancer.fr
  • Rennes, France, 35042
    • Not yet recruiting
    • Centre Eugène Marquis
    • Contact: Susie BROUSSE, Dr; Phone Number: 02 99 25 31 99; Email: s.brousse@rennes.unicancer.fr
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy
    • Contact: Angelica CONVERSANO, Dr; Phone Number: +33 (0)1 42 11 42 11; Email: Angelica.CONVERSANO@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients recruited in 7 centers spread across France

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
magnetic clip localization; The preoperative localization can be performed using several techniques, magnetic clip localization will be use in this cohort	Procedure: magnetic clip localization; magnetic clip 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
wire localization; The preoperative localization can be performed using several techniques, wire localization will be use in this cohort	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; Procedure: metallic wire localization.; metallic wire localization for preoperative localization for breast cancer surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	6 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	At 6 months

Collaborators and Investigators

• Sponsor: Centre Leon Berard

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; cancer; breast cancer surgery; medico-economic; preoperative localization; magnetic clip; wire localization; health economic study; Cost-consequence analysis
• Additional Relevant MeSH Terms: Neoplasms by Site; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Neoplasms; Breast Neoplasms
• Other Study ID Numbers: ET24-213 (MAGNETO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No