MaMaLoc: Magnetic Marker Localisation for non-palpable breast lesions. A Feasibility Study.

All currently available tumour localisation techniques for non-palpable breast
lesions suffer from significant disadvantages, ranging from poor accuracy
(wire-guided localisation) to low uptake due to the laborious nature of
implementing the technique (radioactive techniques).

To assess the clinical safety and feasibility of the MaMaLoc technique: a novel
magnetic localisation technique for intra-operative lesion localisation.

The proposed study is designed as a non-blinded, non-controlled, observational
phase I study in which we assess the feasibility of a novel magnetic medical
device for the localisation of non-palpable breast lesions.

The magnetic MaMaLoc marker is placed in or near the lesion by a radiologist,
in an already locally anesthesized area during the same session as placement of
the iodine seed. Directly prior to the start of the surgeon, a magnetic
detector is used to locate the magnetic marker. After the surgery, the marker
is confirmed present in the excised tissue using the magnetic detector as well
as the pathologist. The rest of the care process is identical to a 'standard'
iodine seed surgery.

Patient burden is limited to one extra injection at the radiology department
during a session that is conventionally used to implant a radio-active marker.
Patient risk is negligible. Detection using low-field magnetism is inherently
safe and the marker is constructed from biocompatible materials.