NCT06906601

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 772 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer
• Medico-economic Impact
• Breast Cancer Surgery

Interventions

Type	Name	Description
PROCEDURE	magnetic clip localization	magnetic clip localization for preoperative localization for breast cancer surgery
PROCEDURE	metallic wire localization.	metallic wire 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

Timeline

• Start date: 2025-04-15
• Primary completion: 2027-10-15
• Completion: 2027-10-15
• First posted: 2025-04-02
• Last updated: 2026-02-17

Locations

7 sites across 1 country: France