Minimally Invasive Excision / Ablation Techniques
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Novilase is indicated for focal destruction of malignant and benign breast tumours of the breast (up to 20 mm). It has received a CE Mark, the first ablation device to be approved for breast cancer. Intended as a minimally-invasive alternative to lumpectomy, it is a percutaneous laser ablation procedure performed with ultrasound image guidance in a breast procedure room. Only local anaesthesia is required, and the procedure may be performed outpatient. For malignant breast tumours, confirmation of ablation effectiveness is obtained by MRI at 1-month post-ablation. Patients may then proceed with radiation and/or adjuvant therapy as indicated. In a Novilase procedure, local anaesthesia is administered, then a 14-gauge laser probe is inserted into the target tumour in a similar manner as an ultrasound guided breast biopsy. A 14-gauge thermal probe with 5 embedded thermistors is then inserted at the periphery of the target ablation zone. An optical laser fibre is inserted through the laser probe and when the laser is activated heating begins from the centre. When the peripheral temperatures reach 60°C, the procedure is complete. A multicentre study in the UK and U.S. demonstrated the effectiveness of Novilase to ablate malignant breast tumours where 98% and 91% of tumours less than or equal to 15 mm and 20 mm respectively were destroyed in one procedure. MRI was shown to correlate with pathology in assessing effectiveness of laser ablation. Patients reported recovery in hours, not days. Patients also reported better health-related quality of life outcomes post-laser than had been reported post-surgery. It is anticipated that fewer re-treatments will be necessary than with standard of care. In the U.S., Novilase is FDA cleared for treatment of benign breast tumours and soft tissue ablation. FDA approved a confirmatory trial for focal destruction of malignant breast tumours that will support marketing approval and several UK sites will participate in that trial. Enrolment is anticipated to begin by mid-2021. Novian Health intends to begin marketing the Novilase device in Europe in 2021.
Schwartzberg, B., et al. Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations. Ann Surg Oncol. 2018; 25(10): 2958–2964. PMID: 29987603.