Breast CancerMAGNETONCT06906601
Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.
An observational study of Breast Cancer and Medico-economic Impact, run by Centre Leon Berard at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Medico-economic Impact, Breast Cancer Surgery
- What is being tested?
- magnetic clip localization, metallic wire localization. and Breast cancer surgery
- Type of treatment
- Surgery or procedure
- How many people
- 772 participants
- Where
- 7 sitesFrance
- Study dates
- 15 Apr 2025to 15 Oct 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients recruited in 7 centers spread across France
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marie Osdoit, Dr contact
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Hospices Civils de Lyon Hopital de la Croix rousse
Lyon, 69004
Marion CORTET, Dr, +33 (0)4 72 11 80 88, marion.cortet@chu-lyon.fr
- Recruiting
Centre Léon Bérard
Lyon, 69008
Marie OSDOIT, Dr, +33 (0)4 78 78 28 28, Marie.OSDOIT@lyon.unicancer.fr
Sophie KLINGLER, Dr, +33 (0)4 78 78 28 28, Sophie.KLINGLER@lyon.unicancer.fr
- Recruiting
Institut de Cancérologie de Lorraine (ICL)
Nancy, 54519
David Manuel GOMES, Dr, +33 (0)3 83 59 84 00, m.gomesdavid@nancy.unicancer.fr
- Recruiting
Hôpital Nord -Ouest Val d'Oise (NOVO)
Pontoise, 95300
Faiza Atmani, Dr, +33 (0)1 30 75 40 40, faiza.atmani@ght-novo.fr
- Recruiting
Institut GODINOT
Reims, 51726
Judicaël HOTTON, Dr, +33 (0)3 26 50 44 44, judicael.hotton@reims.unicancer.fr
- Not yet recruiting
Centre Eugène Marquis
Rennes, 35042
Susie BROUSSE, Dr, 02 99 25 31 99, s.brousse@rennes.unicancer.fr
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Angelica CONVERSANO, Dr, +33 (0)1 42 11 42 11, Angelica.CONVERSANO@gustaveroussy.fr
About this study
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.
Read the 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
- Being tested
- magnetic clip localization, metallic wire localization., Breast cancer surgery
- Keywords
- cancer, breast cancer, breast cancer surgery, preoperative localization, magnetic clip, wire localization, health economic study, Cost-consequence analysis, medico-economic
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic clip localizationProcedure or surgery
magnetic clip localization for preoperative localization for breast cancer surgery
metallic wire localization.Procedure or surgery
metallic wire localization for preoperative localization for breast cancer surgery
Breast cancer surgeryProcedure or 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 group | Role | What they receive |
|---|---|---|
| magnetic clip localization | The preoperative localization can be performed using several techniques, magnetic clip localization will be use in this cohort Receives: Procedure: magnetic clip localization; Procedure: Breast cancer surgery | |
| wire localization | The preoperative localization can be performed using several techniques, wire localization will be use in this cohort Receives: Procedure: metallic wire localization.; Procedure: Breast cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 6 months post surgery
Secondary outcomes (5)
Quality of life of patientes
Quality of life assessed using the 5-level EQ-5D version (EQ-5D-5L).The questionnaire assesses 5 dimensions (Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression). Each dimension is rated on 5 levels (from 1 = no problems to 5 = extreme problems).
Measured: At inclusion, 15 to 30 days after surgery and 6 months after surgery
Satisfaction of radiologist and surgeon
Questionnaire to evaluate the satisfaction of radiologist after the maker placement and questionnaire to evaluate the satisfaction of surgeon after the surgery. The score isn't on a scale.
Measured: Within 24 hours after the maker placement and within 24 hours after the surgery
Patient satisfaction and experience.
Questionnaire after the surgery to evaluated the patient satisfaction and experience. The score isn't on a scale.
Measured: 15 to 30 days after surgery
Budget impact analysis of pre operative magnetic clip localization versus the use of a hookwire.
The decision to include a Budget Impact Analysis (BIA) in this study is in line with the framework agreement signed in January 2016 between the Economic Committee for Medicinal Products (Comité Economique des Produits de Santé - CEPS, in French) and the Pharmaceutical Industry (Les Entreprises du Médicament - LEEM, in French), which advises the implementation of a BIA in addition to the medico-economic study. The BIA will strictly comply with the HAS requirements presented in its methodological guide for BIA.
A budget impact model (BIM) will be developed with the French National health insurance perspective. The cost of the current (hookwire) or new intervention (magnetic clip) mix will be assessed. The population to be included in a BIA will be all patients eligible in France for the new intervention during the time horizon of 3 years. The results will be expressed in incremental budget impact in the first, second and third year.
Measured: At 1, 2 and 3 years
The organisationnal impact of magnetic clip versus metallic wires.
The organizational analysis will be based on performance indicators of magnetic clips compared to metallic wires, such as the number of patient visits to the hospital before surgery, the number of localization procedures performed on the day of the intervention, the length of stay, waiting times, and the number of emergency visits throughout the follow-up period. The stochastic variables (lengths of stay, intervals between stays) will be modeled using appropriate statistical distributions, determined by maximum likelihood estimation based on statistical analyses of the extracted data.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start15 Apr 2025
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 772 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906601
- Sponsor's protocol ID
- ET24-213 (MAGNETO)
- Acronym
- MAGNETO
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No