Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.
MAGNETO
1 other identifier
observational
772
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2025
CompletedFirst Posted
Study publicly available on registry
April 2, 2025
CompletedStudy Start
First participant enrolled
April 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 15, 2027
February 17, 2026
February 1, 2026
2.5 years
March 18, 2025
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Quality of life of patientes
At inclusion, 15 to 30 days after surgery and 6 months after surgery
Satisfaction of radiologist and surgeon
Within 24 hours after the maker placement and within 24 hours after the surgery
Patient satisfaction and experience.
15 to 30 days after surgery
Budget impact analysis of pre operative magnetic clip localization versus the use of a hookwire.
At 1, 2 and 3 years
The organisationnal impact of magnetic clip versus metallic wires.
At 6 months
Study Arms (2)
magnetic clip localization
The preoperative localization can be performed using several techniques, magnetic clip localization will be use in this cohort
wire localization
The preoperative localization can be performed using several techniques, wire localization will be use in this cohort
Interventions
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
magnetic clip localization for preoperative localization for breast cancer surgery
Eligibility Criteria
Patients recruited in 7 centers spread across France
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Hospices Civils de Lyon Hopital de la Croix rousse
Lyon, 69004, France
Centre Léon Bérard
Lyon, 69008, France
Institut de Cancérologie de Lorraine (ICL)
Nancy, 54519, France
Hôpital Nord -Ouest Val d'Oise (NOVO)
Pontoise, 95300, France
Institut GODINOT
Reims, 51726, France
Centre Eugène Marquis
Rennes, 35042, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2025
First Posted
April 2, 2025
Study Start
April 15, 2025
Primary Completion (Estimated)
October 15, 2027
Study Completion (Estimated)
October 15, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02