MTAK
Research type
Research Study
Full title
Microwave therapy for treatment of precancerous actininc keratoses
IRAS ID
240421
Contact name
Charlotte Proby
Contact email
Sponsor organisation
University of Dundee
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This study is a collaboration between the University of Dundee, NHS Tayside and Emblation Ltd, funded by Innovate UK. Emblation is a Scottish based SME working in the field of microwave medical devices.
Actinic keratoses (AK) are believed the most common pre-cancerous lesions in humans and are precursors to invasive cutaneous squamous cell carcinoma (cSCC). AK are readily identified clinically on sun-damaged skin so AK treatment offers an important opportunity for cancer prevention, but our ability to treat is limited by undesirable local adverse reactions from existing topical treatments which fail to balance effectiveness, side effects and cost. None of the currently available treatments for AK are suitable for widespread use in the community and all are only partially effective.
Our hypothesis is that localised microwave energy therapy is a suitable treatment for AK skin lesions. The use of microwave technology is well established as ablative doses for treatment of malignancy e.g. hepatocellular carcinoma. Emblation already have a CE marked microwave instrument used for the successful treatment of plantar viral warts, the SWIFT device. We now wish to undertake a feasibility trial in 12 participants, each with multiple AK on dorsal hand skin or bald scalp or both. The trial will examine the tolerability, acceptability, efficacy and long term resolution of AK following one or more treatments with microwave energy delivered using the SWIFT device.
This will be a single site, two-stage study. Stage 1 will measure the electrical properties of AKs in patients using very low levels of energy. The data allows derivation of the power settings (or "dose of microwave energy") to be used with SWIFT for AK in stage 2, to conduct a randomised, internally controlled trial of microwave treatment, delivered using SWIFT, versus no treatment.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
18/ES/0008
Date of REC Opinion
26 Jan 2018
REC opinion
Favourable Opinion