Effectiveness and Safety of Preoperative Magnetic Detection of Non-palpable Breast Lesions

Breast Cancer Clinical Trial

— MAGREES  

Official title:

Effectiveness and Safety of Preoperative Magnetic Detection of Non-palpable Breast Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05327218
• Other study ID #: MAGREES
• Status: Completed
• Start date: March 20, 2022
• Est. completion date: March 6, 2023

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Breast cancer is the most common cancer in women and also has the highest death rate. In 2018, 58,500 new cases were diagnosed in metropolitan France. It affects, in 8 out of 10 cases, women aged 50 and over. Nevertheless, thanks to early detection and improved therapeutic techniques, its mortality rate has continued to decrease each year (a decrease of 1.6% per year was recorded between 2010 and 2018), which allows it to maintain its status as a cancer with a good prognosis. Furthermore, net survival is 87% at 5 years and 76% at 10 years. The median age of death is 74 years. Organized screening was initiated in France in 1990 and generalized in 2004, while maintaining a specific management according to the personal risk of each patient. It consists of a mammogram, plus or minus an ultrasound, every two years from the age of 50. The mammogram is reviewed by two different radiologists. In case of abnormality, a biopsy is performed.

Breast lesions are separated into two nosological entities: palpable tumors, often diagnosed on clinical examination (or autopalpation) and confirmed on mammography, and non-palpable tumors detected during mammographic and/or ultrasound screening.

Thanks to the generalization of screening, the detection of subclinical lesions requiring surgery represents more than half of the breast surgeries and the challenge of their surgical management lies in a precise preoperative location to allow a complete removal, while limiting the sacrifice of healthy glandular tissue. The metallic location technique is currently the reference technique for the preoperative location of these lesions.

For all these reasons, new techniques of preoperative tracking have been developed.

Magnetic tracking (MR) appears to be a simple, non-radioactive and non-aggressive technique to use and organize. MR takes the form of a 1x5mm paramagnetic clip made of iron oxide visible on ultrasound and mammography and is detected by a SentiMag probe. The MR began to be used in France in 2017. It is placed in contact with the lesion under ultrasound guidance. It has the advantage that it can be placed up to 30 days before surgery and has less risk of complication. This MR contains iron particles and is 5mm long. It is pre-loaded in a sterile 18 G needle closed with a wax tip. It is deployed under mammographic and/or ultrasound guidance. The Sentimag probe is used to detect MR in a multidirectional way at 360°, with an audio and visual estimation of the distance. It generates an alternating magnetic field that magnetizes the iron in the MR.

All of these surgical procedures can be performed as outpatient surgery, which corresponds to a hospitalization of less than 12 hours without overnight accommodation, meaning that each patient is admitted and discharged on the same day as her procedure. Outpatient surgery represented 36% of all surgeries in France in 2018. The objective of the HAS is to achieve a majority ambulatory practice of 70% by 2022. This type of surgery has advantages for the patient, by making her journey safer: reduction in the risk of nosocomial infection, thromboembolic risk and anxiety linked to hospitalization for the patient and her family. It also has an important socio-economic advantage by reducing hospitalization costs and the number of hospital beds required. It improves the working conditions of the staff by reducing the workload and night shifts. It has also enabled a clear improvement in the optimization and efficiency of the organization of resources in the surgical technical platforms. The role of the MR is particularly well suited to this new organization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 6, 2023
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient whose age = 18 years

• Patient with non-palpable benign, atypical or cancerous lesions

• Preoperative biopsy

• Requiring surgical excision

• French speaking patient

Exclusion Criteria:

• Palpable breast lesion

• Contraindication to the installation of a magnetic tracer

• Patient under guardianship or curatorship

• Patient deprived of liberty

• Patient under court protection

• Patient opposing the use of his data for this research

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (8)

Broeders M, Moss S, Nystrom L, Njor S, Jonsson H, Paap E, Massat N, Duffy S, Lynge E, Paci E; EUROSCREEN Working Group. The impact of mammographic screening on breast cancer mortality in Europe: a review of observational studies. J Med Screen. 2012;19 Suppl 1:14-25. doi: 10.1258/jms.2012.012078. — View Citation

Chagpar AB, Garcia-Cantu C, Howard-McNatt MM, Gass JS, Levine EA, Chiba A, Lum S, Martinez R, Brown E, Dupont E; SHAVE2 authors. Does Localization Technique Matter for Non-palpable Breast Cancers? Am Surg. 2022 Dec;88(12):2871-2876. doi: 10.1177/00031348211011135. Epub 2021 Apr 15. — View Citation

Frank HA, Hall FM, Steer ML. Preoperative localization of nonpalpable breast lesions demonstrated by mammography. N Engl J Med. 1976 Jul 29;295(5):259-60. doi: 10.1056/NEJM197607292950506. No abstract available. — View Citation

Hall FM, Frank HA. Preoperative localization of nonpalpable breast lesions. AJR Am J Roentgenol. 1979 Jan;132(1):101-5. doi: 10.2214/ajr.132.1.101. — View Citation

Jeffries DO, Dossett LA, Jorns JM. Localization for Breast Surgery: The Next Generation. Arch Pathol Lab Med. 2017 Oct;141(10):1324-1329. doi: 10.5858/arpa.2017-0214-RA. — View Citation

Norman C, Lafaurie G, Uhercik M, Kasem A, Sinha P. Novel wire-free techniques for localization of impalpable breast lesions-A review of current options. Breast J. 2021 Feb;27(2):141-148. doi: 10.1111/tbj.14146. Epub 2020 Dec 27. — View Citation

Pieszko K, Wichtowski M, Cieciorowski M, Jamont R, Murawa D. Evaluation of the nonradioactive inducible magnetic seed system Magseed for preoperative localization of nonpalpable breast lesions - initial clinical experience. Contemp Oncol (Pozn). 2020;24(1):51-54. doi: 10.5114/wo.2020.93677. Epub 2020 Mar 13. — View Citation

Shapiro S. Periodic screening for breast cancer: the HIP Randomized Controlled Trial. Health Insurance Plan. J Natl Cancer Inst Monogr. 1997;(22):27-30. doi: 10.1093/jncimono/1997.22.27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of magnetic tracking	This outcome corresponds to the number of patients with complete removal of the target lesion.	Day 1
Secondary	Safety of magnetic tracking	This outcome corresponds to the occurrence of complications related to the placement of the metallic or magnetic marker.	Day 1

External Links

•   Cancer du sein (II). Procédures diagnostiques et thérapeutiques
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