Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Leon Berard
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Patients recruited in 7 centers spread across France
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
magnetic clip localization
Procedure/Surgerymagnetic clip localization for preoperative localization for breast cancer surgery
metallic wire localization.
Procedure/Surgerymetallic wire localization for preoperative localization for breast cancer surgery
Breast cancer surgery
Procedure/SurgeryPatient 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
Treatment groups
772 Participants
are divided into 2 treatment groupsGroup A: magnetic clip localization2 interventions
Group B: wire localization2 interventions
Trial outcomes
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.
Time frame
6 months post surgerySecondary outcomes
1
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 surgery2
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 surgery3
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 surgery4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov