Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 772
- 试验地点
- 13
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged ≥ 18 years;
- •Patient presenting with a unifocal and unilateral lesion of invasive carcinoma or in situ;
- •Indication for first breast-conserving treatment with the need for preoperative localization of the lesion, regardless of the associated lymph node procedure;
- •Patient affiliated with a health insurance system;
- •Non-opposition to the study.
排除标准
- •Psychological, family, or sociological condition that may potentially compromise adherence to the treatment protocol and follow-up;
- •Bilateral surgery required;
- •Patient with metastatic breast cancer;
- •Multifocal or benign lesions;
- •Pregnant or breastfeeding patient;
- •Need for neoadjuvant treatment;
- •Patient under guardianship, curatorship, or deprived of liberty.
研究组 & 干预措施
magnetic clip localization
The preoperative localization can be performed using several techniques, magnetic clip localization will be use in this cohort
干预措施: magnetic clip localization (Procedure)
magnetic clip localization
The preoperative localization can be performed using several techniques, magnetic clip localization will be use in this cohort
干预措施: Breast cancer surgery (Procedure)
wire localization
The preoperative localization can be performed using several techniques, wire localization will be use in this cohort
干预措施: metallic wire localization. (Procedure)
wire localization
The preoperative localization can be performed using several techniques, wire localization will be use in this cohort
干预措施: Breast cancer surgery (Procedure)
结局指标
主要结局
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
时间窗: 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.
次要结局
- Quality of life of patientes(At inclusion, 15 to 30 days after surgery and 6 months after surgery)
- Budget impact analysis of pre operative magnetic clip localization versus the use of a hookwire.(At 1, 2 and 3 years)
- 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)
- The organisationnal impact of magnetic clip versus metallic wires.(At 6 months)