A Randomised Clinical Trial comparing Magseed® with Guide Wire localization in nonpalpable breast cancer scheduled for Magtrace® assisted sentinel lymph node biopsy: The MagTotal RCT

• Guidewire localization is widely regarded as the gold standard method of localizing non-palpable breast tumors even though it has drawbacks. Magnetic seed (magseed®) localization is a safe and feasible alternative for localizing and excising non-palpable breast tumors. The combination of magnetic seed localization together with superparamagnetic iron oxide nanoparticles (SPIO) for breast cancer scheduled for breast-conserving surgery (BCS) together with sentinel lymph node biopsy (SLNB) have also been reported. In this multicentre randomized pilot study, we aimed to compare localization with either Magseed® or guidewire in breast cancer patients scheduled for BCS + SLNB between September 2018 and May 2021. All patients received SPIO peritumoral and preoperatively for identification of the sentinel lymph nodes (SLN). If randomized to magseed® localization (n = 91) the patient received it by the radiologist up until 30 days before surgery and if allocated to guidewire localization (n = 116) the patient received it on the day of the surgery. All patients were injected with SPIO, ultrasound guided by radiologist if allocated to magnetic seed or by the surgeon if allocated to guidewire, up until 30 days before surgery. Primary endpoint was reoperation rate due to positive margins. In 207 patients (n = 91 in magseed and n = 116 in guidewire) there was no significant difference in reoperation rate (3.3% in magseed vs 7% in guidewire group, p = 0.354). Furthermore, there was no significant difference in SLN detection rate (97.8% vs 100%, p = 0.187) and both groups had comparable mean number of SLNs retrieved (2.52 vs 2.62 nodes, p = 0.763). Magnetic seed localization together with SPIO for SLNB is a viable and safe alternative to guidewire localization. 

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kirurgi (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Surgery (hsv//eng)

Nyckelord

breast cancer

superparamagnetic iron oxide nanoparticles

breast conserving surgery

sentinel lymph node biopsy

Surgery

Kirurgi

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