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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура magnetic clip localization
  magnetic clip localization for preoperative localization for breast cancer surgery
• Процедура metallic wire localization.
  metallic wire localization for preoperative localization for breast cancer surgery
• Процедура 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

Первичные конечные точки

• 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 [Срок оценки: 6 months post surgery]

Вторичные конечные точки (5)

• Quality of life of patientes [Срок оценки: At inclusion, 15 to 30 days after surgery and 6 months after surgery]
• Satisfaction of radiologist and surgeon [Срок оценки: Within 24 hours after the maker placement and within 24 hours after the surgery]
• Patient satisfaction and experience. [Срок оценки: 15 to 30 days after surgery]
• Budget impact analysis of pre operative magnetic clip localization versus the use of a hookwire. [Срок оценки: At 1, 2 and 3 years]
• The organisationnal impact of magnetic clip versus metallic wires. [Срок оценки: At 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.8. Patient under guardianship, curatorship, or deprived of liberty.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 7 центров

• Hospices Civils de Lyon Hopital de la Croix rousse — Lyon
• Centre Léon Bérard — Lyon
• Institut de Cancérologie de Lorraine (ICL) — Nancy
• Hôpital Nord -Ouest Val d'Oise (NOVO) — Pontoise
• Institut GODINOT — Reims
• Centre Eugène Marquis — Rennes
• Institut Gustave Roussy — Villejuif

Идентификаторы

NCT: NCT06906601 · ET24-213 (MAGNETO)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗