Microwave Therapy for Treatment of Precancerous Actinic Keratoses

NCT03483935 | Completed Results

• 1 other identifier: 2016DS12
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-stage feasibility study to determine if focussed microwave energy is a suitable treatment for Actinic Keratoses (AK). The two study stages are as follows: Stage 1: To determine the electrical properties of permittivity in AK on the hand and bald scalp for subsequent optimisation of the SWIFT instrument to provide the correct dose of microwave energy to the AK. Stage 2:

1. 1.Evaluate the efficacy of microwave energy as a treatment for AK
2. 2.Evaluate the long-term resolution of AK following microwave treatment
3. 3.Assess the feasibility and acceptability of using microwave energy as a treatment for AK
4. 4.Identify the potential mode of action of microwave energy in the treatment of AK.

Conditions

Actinic Keratoses; Precancerous Skin Lesion

Outcome Measures

Primary Outcomes (3)

• Resolution of AK Lesions Following Microwave Treatment

  The resolution of each treated AK lesion will be determined by clinical assessment. Resolution is predetermined as either partial (resolution of the area covered by the microwave probe, but with a rim or persistent AK) or full (complete resolution of the entire AK) over all time periods. Response will be assessed at visits 3 (day 8), 4 (day 15), 6 (day 28), 8 (day 42), 10 (day 60) and 11 (day 120). Mixed-effects logistic regression models analysed the effect of microwave therapy with random effects for participant and visit (≤ 6 per participant). Each visit will be analysed as a categorical variable as they were spaced unequally in time. Variables representing sex, age, skin site (hand/scalp) and AK subtype (thick/thin) will be included as covariates. The data reported in the outcome table is the number of resolved AK lesions.

  Baseline, day 8, 15, 28, 42, 60 and 120

• Complete Resolution of AKs Following Microwave Treatment

  The resolution of each treated AK lesion will be determined by clinical assessment. Resolution is predetermined as either partial (resolution of the area covered by the microwave probe, but with a rim or persistent AK) or full (complete resolution of the entire AK) over all time periods. Treatment will be given at day 1, with a second treatment on day 28 based on a clinical decision. Response will be assessed at visits 3 (day 8), 4 (day 15), 6 (day 28), 8 (day 42), 10 (day 60) and 11 (day 120). Clinical photos will be taken at each hospital visit. Mixed-effects logistic regression models analysed the effect of microwave therapy with random effects for participant and visit (≤ 6 per participant). Each visit will be analysed as a categorical variable as they were spaced unequally in time. Variables representing sex, age, skin site (hand/scalp) and AK subtype (thick/thin) will be included as covariates.

  Baseline, day 8, 15, 28, 42, 60 and 120

• Partial Resolution of AKs Following Microwave Treatment

  The resolution of each treated AK lesion will be determined by clinical assessment. Resolution is predetermined as either partial (resolution of the area covered by the microwave probe, but with a rim or persistent AK) or full (complete resolution of the entire AK) over all time periods. Treatment will be given at day 1, with a second treatment on day 28 based on a clinical decision. Response will be assessed at visits 3 (day 8), 4 (day 15), 6 (day 28), 8 (day 42), 10 (day 60) and 11 (day 120). Clinical photos will be taken at each hospital visit. Mixed-effects logistic regression models analysed the effect of microwave therapy with random effects for participant and visit (≤ 6 per participant). Each visit will be analysed as a categorical variable as they were spaced unequally in time. Variables representing sex, age, skin site (hand/scalp) and AK subtype (thick/thin) will be included as covariates.

  Baseline, day 8, 15, 28, 42, 60 and 120

Secondary Outcomes (4)

• Level of Pain Experienced During Treatment

  Treatment 1 (day 1) and treatment 2 (day 28)

• Duration of Pain Post Treatment

  Treatment 1 (day 1) and Treatment 2 (day 28)

• Change in Ki67 Staining Determined Immunohistochemically by the Use of Specific Antibodies on Fixed Material

  Day 15

• Change in Hematoxylin and Eosin Stain

  Day 15 OR day 42

Study Arms (2)

Microwave energy treatment

EXPERIMENTAL

The microwave treatment will be delivered using the microwave instrument, SWIFT, manufactured by Emblation and CE marked for this indication, will be used to deliver the microwave treatment. The microwave dose will be between 2 Watt and 4 Watt. The treatment will consist of 3, 2 to 3 second bursts delivered to the same lesion with 5-20 seconds between bursts.

Other: Microwave treatment

Control

NO INTERVENTION

No treatment will be given.

Interventions

Microwave treatment OTHER

Microwave energy delivered using the microwave instrument, SWIFT, manufactured by Emblation and CE marked for dermatology applications.

Microwave energy treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants
• Age 18 years and over
• Clinical diagnosis of precancerous Actinic Keratosis made by a dermatologist
• Able to perform study assessments

You may not qualify if:

• Inability to give informed consent
• Implantable Cardioverter-defibrillator (ICD), pacemaker or other implantable device
• Metal implants at site of treatment
• Known allergy or intolerance to microwave therapy
• Unstable co-morbidities (cardiovascular disease, active malignancy, vasculopathy, inflammatory arthritis) which, in the opinion of the Chief Investigator (CI), would make the patient unsuitable to be enrolled in the study.
• Individuals who are immunosuppressed (organ transplant recipients, haematologic malignancies, HIV).
• Individuals will not be enrolled to the study if they are participating in the clinical phase of another interventional trial or have done so within the last 30 days. Individuals who are participating in the follow-up phase of another interventional trial, or who are enrolled in an observational study, will be co-enrolled where the CIs of each study agree that it is appropriate.

Sponsors & Collaborators

• University of Dundee: lead
• Emblation Limited: collaborator

Study Sites (1)

NHS Tayside

Dundee, DD1 9SY, United Kingdom

Location

Related Publications (9)

• Bristow I, Lim WC, Lee A, Holbrook D, Savelyeva N, Thomson P, Webb C, Polak M, Ardern-Jones MR. Microwave therapy for cutaneous human papilloma virus infection. Eur J Dermatol. 2017 Oct 1;27(5):511-518. doi: 10.1684/ejd.2017.3086.

  PMID: 29084638 BACKGROUND

• Criscione VD, Weinstock MA, Naylor MF, Luque C, Eide MJ, Bingham SF; Department of Veteran Affairs Topical Tretinoin Chemoprevention Trial Group. Actinic keratoses: Natural history and risk of malignant transformation in the Veterans Affairs Topical Tretinoin Chemoprevention Trial. Cancer. 2009 Jun 1;115(11):2523-30. doi: 10.1002/cncr.24284.

  PMID: 19382202 BACKGROUND

• Eder J, Prillinger K, Korn A, Geroldinger A, Trautinger F. Prevalence of actinic keratosis among dermatology outpatients in Austria. Br J Dermatol. 2014 Dec;171(6):1415-21. doi: 10.1111/bjd.13132. Epub 2014 Nov 19.

  PMID: 24864059 BACKGROUND

• Goon PK, Greenberg DC, Igali L, Levell NJ. Squamous Cell Carcinoma of the Skin has More Than Doubled Over the Last Decade in the UK. Acta Derm Venereol. 2016 Aug 23;96(6):820-1. doi: 10.2340/00015555-2310. No abstract available.

  PMID: 26631391 BACKGROUND

• Liang P, Wang Y. Microwave ablation of hepatocellular carcinoma. Oncology. 2007;72 Suppl 1:124-31. doi: 10.1159/000111718. Epub 2007 Dec 13.

  PMID: 18087193 BACKGROUND

• Marks R, Rennie G, Selwood TS. Malignant transformation of solar keratoses to squamous cell carcinoma. Lancet. 1988 Apr 9;1(8589):795-7. doi: 10.1016/s0140-6736(88)91658-3.

  PMID: 2895318 BACKGROUND

• Martin R.C.G. (2011) Microwave Ablation and Hepatocellular Carcinoma. In: McMasters K. (eds) Hepatocellular Carcinoma:. Springer, New York, NY

  BACKGROUND

• Poggi G, Tosoratti N, Montagna B, Picchi C. Microwave ablation of hepatocellular carcinoma. World J Hepatol. 2015 Nov 8;7(25):2578-89. doi: 10.4254/wjh.v7.i25.2578.

  PMID: 26557950 BACKGROUND

• Wang T, Lu XJ, Chi JC, Ding M, Zhang Y, Tang XY, Li P, Zhang L, Zhang XY, Zhai B. Microwave ablation of hepatocellular carcinoma as first-line treatment: long term outcomes and prognostic factors in 221 patients. Sci Rep. 2016 Sep 13;6:32728. doi: 10.1038/srep32728.

  PMID: 27620527 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Prof Charlotte Proby
• Organization: University of Dundee

c.proby@dundee.ac.uk

+44 1382 383289

Study Officials

• Charlotte Proby, MBCHB

  University of Dundee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, internally controlled trial

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 30, 2018
• Study Start: March 7, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: March 6, 2023
• Results First Posted: February 23, 2021

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)