Photographing the Skin During Photodynamic Therapy

Study Overview
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Brief Summary
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Photodynamic therapy (PDT) is used to treat some types of sun-damaged skin and low-grade forms of growths. A cream is applied to the skin, and the chemical in this cream is absorbed in to the skin and converted in to a 'photosensitiser'. This photosensitiser is fluorescent, meaning that it produces red light when blue light is shone on it. By measuring how much light is given off with a camera, the investigators can determine how much photosensitiser is present in the skin. Also, it is thought that more of the chemical is converted to the active photosensitiser if the skin is warmer, so the investigators plan to measure the temperature of the skin using a thermal camera. Light is shone on to the skin and this activates the photosensitiser, treating the problem area and leaving healthy skin intact. This research will increase the investigators understanding of how PDT works, and may help the investigators to improve treatment regimens so that they can be made more effective and better tolerated

Official Title
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Fluorescence and Thermal Imaging of the Skin Before and During Photodynamic Therapy

Conditions
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Basal Cell Carcinoma, Bowen's Disease

Intervention / Treatment
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* Device: Fluorescence and thermal imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients presenting with superficial BCC or Bowen's disease (one or two lesions and diagnosed either clinically or histologically and untreated or having had no treatment for 4 months or longer) 2. Adult males and females, >18 years only 3. Capable of giving informed consent 4. Able to understand and adhere to protocol requirements Exclusion Criteria: 1. Patients skin lesions have had previous treatment in the last 4 months 2. Unable to give informed consent 3. Known allergy to Metvix® 4. Known to have a light sensitive disorder 5. Pregnant, breastfeeding or planning to conceive

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br> | Device: Fluorescence and thermal imaging<br>* Two cameras used to take images of the skin. One, to measure the fluorescence from the photosensitiser, and the second to measure the surface temperature of the skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is there a correlation between body site temperature and degree of fluorescence prior to and/or during PDT | Body site temperature is measured before and during PDT (in degrees Celsius) as is fluorescence signal (in arbitrary fluorescence units). These are compared for each time point in the treatment for each patient. | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is there a correlation between temperature and/or fluorescence and treatment outcome | Following from Outcome 1, these data for each patient will be compared with the clinical outcome (determined visually by Dermatologist) at 3 and 12 months, to see if there is a correlation between either measurements and clinical outcome. | 12months | 
| How does the spatial distribution of fluorescence and temperature change prior to and during PDT | Fluorescence and thermal cameras record field of view data, so the investigators can investigate how the fluorescence and thermal distribution in the lesions changes during treatment. | 12months | 
| Pain measured immediately after irradiation | Pain (visual analogue scale 1-10 cm-1) is measured after treatment, and the investigators will check for correlations between this properties and the fluorescence and thermal readings for each patient. | 12months | 
| phototoxicity (inflammation) measured immediately after irradiation | inflammation (measured visually by a Dermatologist) is measured after treatment, and the investigators will check for correlations between this property and the fluorescence and thermal readings for each patient. | 12months |