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Clinical Trial
. 2018 Jun;169(3):531-536.
doi: 10.1007/s10549-018-4709-y. Epub 2018 Feb 16.

Safety and feasibility of breast lesion localization using magnetic seeds (Magseed): a multi-centre, open-label cohort study

James R Harvey  1 , Yit Lim  2 , John Murphy  2 , Miles Howe  2 , Julie Morris  2 , Amit Goyal  3 , Anthony J Maxwell  2   4
Affiliations
Clinical Trial

Safety and feasibility of breast lesion localization using magnetic seeds (Magseed): a multi-centre, open-label cohort study

James R Harvey et al. Breast Cancer Res Treat. 2018 Jun.

Abstract

Purpose: Wire localization has several disadvantages, notably wire migration and difficulty scheduling the procedure close to surgery. Radioactive seed localization overcomes these disadvantages, but implementation is limited due to radiation safety requirements. Magnetic seeds potentially offer the logistical benefits and transcutaneous detection equivalence of a radioactive seed, with easier implementation. This study was designed to evaluate the feasibility and safety of using magnetic seeds for breast lesion localization.

Methods: A two-centre open-label cohort study to assess the feasibility and safety of magnetic seed (Magseed) localization of breast lesions. Magseeds were placed under radiological guidance into women having total mastectomy surgery. The primary outcome measure was seed migration distance. Secondary outcome measures included accuracy of placement, ease of transcutaneous detection, seed integrity and safety.

Results: Twenty-nine Magseeds were placed into the breasts of 28 patients under ultrasound guidance. There was no migration of the seeds between placement and surgery. Twenty-seven seeds were placed directly in the target lesion with the other seeds being 2 and 3 mm away. All seeds were detectable transcutaneously in all breast sizes and at all depths. There were no complications or safety issues.

Conclusions: Magnetic seeds are a feasible and safe method of breast lesion localization. They can be accurately placed, demonstrate no migration in this feasibility study and are detectable in all sizes and depths of breast tissue. Now that safety and feasibility have been demonstrated, further clinical studies are required to evaluate the seed's effectiveness in wide local excision surgery.

Keywords: Breast cancer; Lumpectomy; Magnetic; Mastectomy; Seed localization.

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Conflict of interest statement

Conflicts of interest

All the authors declare they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Figures

Fig. 1
Fig. 1
Magseed Structure—Magseed consists of a 5 × 1 mm paramagnetic steel seed which does not have the barbs of a traditional wire used for localization
Fig. 2
Fig. 2
Spearman correlation between Depth of Magseed marker on Ultrasound and the Highest recorded count on the Sentimag detector. The deeper the seed is placed in the breast the lower the reading recorded on the Sentimag device and the longer it took to detect the device
See this image and copyright information in PMC

References

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