Clinical trial NCT06906601: Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.
Official title: Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Medico-economic Impact
Breast Cancer Surgery
Keywords: cancer
breast cancer
breast cancer surgery
preoperative localization
magnetic clip
wire localization
health economic study
Cost-consequence analysis
medico-economic
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 772
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited in 9 centers spread across France

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.

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.

Eligibility criteria: 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.7. Associated breast reduction procedure;
* E.8. Patient under guardianship, curatorship, or deprived of liberty.

Primary outcomes:
measure: 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
timeFrame: 6 months post surgery
Secondary outcomes:
measure: Quality of life of patientes
timeFrame: At inclusion, 15 to 30 days after surgery and 6 months after surgery
measure: Satisfaction of radiologist and surgeon
timeFrame: Within 24 hours after the maker placement and within 24 hours after the surgery
measure: Patient satisfaction and experience.
timeFrame: 15 to 30 days after surgery
measure: Budget impact analysis of pre operative magnetic clip localization versus the use of a hookwire.
timeFrame: At 1, 2 and 3 years
measure: The organisationnal impact of magnetic clip versus metallic wires.
timeFrame: At 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon Hopital de la Croix rousse
city: Lyon
country: France
facility: Centre Léon Bérard
city: Nancy
country: France
facility: Institut de Cancérologie de Lorraine (ICL)
city: Pontoise
country: France
facility: Hôpital Nord -Ouest Val d'Oise (NOVO)
city: Reims
country: France
facility: Institut GODINOT
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest Rene Gauducheau
city: Toulouse
country: France
facility: IUCT-Toulouse
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: