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Microwave Therapy for Treatment of Precancerous Actinic Keratoses (MTAK)

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ClinicalTrials.gov Identifier: NCT03483935
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
Emblation Limited
Information provided by (Responsible Party):
University of Dundee

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

The primary objective is to evaluate the efficacy of microwave therapy versus no treatment on the resolution of AK lesions using visual assessment. The primary outcome measure is greater than 25% full or partial resolution of the AK assessed by skin examination.


Condition or disease Intervention/treatment Phase
Actinic Keratoses Precancerous Skin Lesion Other: Microwave treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, internally controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microwave Therapy for Treatment of Precancerous Actinic Keratoses
Actual Study Start Date : March 7, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Arm Intervention/treatment
Experimental: Microwave energy treatment
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. A measured dose, determined from data acquired from Stage 1 of this study, will be used per AK.
Other: Microwave treatment
Microwave energy delivered using the microwave instrument, SWIFT, manufactured by Emblation and CE marked for dermatology applications.

No Intervention: Control
No treatment will be given.



Primary Outcome Measures :
  1. Change in AK resolution following microwave treatment [ Time Frame: Baseline, day 8, 15, 28, 42, 60 and 120 ]
    Clinical examination of affected skin


Secondary Outcome Measures :
  1. Number of participants with treatment related adverse events [ Time Frame: Baseline, day 8, 15, 28, 42, 60 and 120 ]
    To evaluate the safety and tolerability of microwave treatment as a therapy for AK. Participants will be asked about level and duration of pain during and immediately after treatment. Participants will be asked about the presence of tingling or numbness, itching, red of flaky skin or ulceration.

  2. Change in Ki67 staining determined immunohistochemically by the use of specific antibodies on fixed material [ Time Frame: Day 15 OR day 42 ]
    To identify the mode of action of microwave treatment on biomarkers of cell proliferation as a therapy for AK

  3. Change in Hematoxylin and eosin stain [ Time Frame: Day 15 OR day 42 ]
    To identify the mode of action of microwave treatment on biomarkers of cell survival

  4. Change in apoptotic cells determined using the ApopTag peroxidase detection kit [ Time Frame: Day 15 OR day 42 ]
    To identify the mode of action of microwave treatment on biomarkers of stress response

  5. Change in gene activity determined by ApopTag Peroxidase [ Time Frame: Day 15 OR day 42 ]
    To identify the mode of action of microwave treatment on gene activity



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to give informed consent
  • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483935


Locations
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United Kingdom
NHS Tayside
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Emblation Limited
Investigators
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Principal Investigator: Charlotte Proby, MBCHB University of Dundee
  Study Documents (Full-Text)

Documents provided by University of Dundee:
Study Protocol  [PDF] February 2, 2018


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

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Responsible Party: University of Dundee
ClinicalTrials.gov Identifier: NCT03483935     History of Changes
Other Study ID Numbers: 2016DS12
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms