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.
Disclosures
Did you receive any funding to support your research for this TOPIC?
Yes
Please specify entities (individual, company, society): Pulse Biosciences
Were you provided with any honoraria, payment or other compensation for your work on this study?
Yes
Please specify entities (individual, company, society): Research Funding for study costs, Consulting fees
Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No
Please specify entities (individual, company, society): no
Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No
This work is presented thanks to the support of: Pulse Biosciences