Objectives: This study was designed to evaluate the histologic and immunologic response of a novel technology, nanopulse stimulation for the treatment of nodular Basal Cell Carcinoma
Introduction: Nano-Pulse Stimulation (NPS) technology is a non-thermal treatment modality that delivers nano-second range electrical energy pulses to targeted tissue. NPS pulses act directly on cells within the NPS treatment zone and cause irreversible apoptosis. Pre-clinical models of in situ NPS treated malignant tumors, in a murine model, demonstrated direct elimination of tumor cells, that subsequently trigger release of tumor antigens which stimulate a lasting in situ anti-tumor immune T-cell response. The surrounding non-cellular dermis remains undamaged.
Materials / method: In this multi-center study, adult subjects with non-facial nodular BCC lesions with a minimum lesion size of 5x8 mm, were enrolled. Prior to planned lesion excision, ~50% of the nBCC surface area was treated with a single NPS session. NPS setting was randomized to one of 3 energy levels (3.9J, 7.7J and 15.5J), using a 5x5mm tip. The time between the NPS exposure and lesion excision ranged from 21 to 47 days, with an average of 27 days. Bulk lesion was excised to evaluate presence/absence of residual BCC in known treatment zone and characterize the inflammatory infiltrate.
Results: Pre- and post-treatment biopsies from subset of seven biopsy-confirmed nBCCs were evaluated histologically. As previously reported, 100% (n=7) of histology samples of the NPS treated zone of bulk cut lesions were rated devoid/absence of residual BCC across all energy settings. Of note, CD8+ T-cell inflammatory infiltrate was detected in some histologic samples of the untreated nBCC tissue. Clinical assessment of pre- and post-treatment photographs and histology indicate that the 5 lesions treated with the two lowest settings (3.9J and 7.7J) demonstrated rapid healing with favorable cosmetic results
Conclusion: NPS technology has promising potential for the treatment of the nodular BCC-subtype based on the complete absence of nBCCs within the NPS treatment zone. Assessment of clinical photographs and histology suggests favorable cosmetic outcomes and a reduced potential for scar formation at the lower energy settings, a major benefit compared to surgical excision of these deep nodular lesions which typically result in a permanent, obvious scar. NPS studies with a larger population are needed to validate these positive findings.
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