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

Condition(s) studied

Investigational drug(s) / intervention(s)

magnetic clip localization: magnetic clip localization for preoperative localization for breast cancer surgery

metallic wire localization.: metallic wire localization for preoperative localization for breast cancer surgery

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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 — 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.

Trial sites (7)

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