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Clinical Trials/NCT03167762
NCT03167762
Completed
Not Applicable

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

University of Dundee1 site in 1 country18 target enrollmentStarted: June 22, 2017Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
1
Primary Endpoint
Is there a correlation between body site temperature and degree of fluorescence prior to and/or during PDT

Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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)
  • Adult males and females, \>18 years only
  • Capable of giving informed consent
  • Able to understand and adhere to protocol requirements

Exclusion Criteria

  • Patients skin lesions have had previous treatment in the last 4 months
  • Unable to give informed consent
  • Known allergy to Metvix®
  • Known to have a light sensitive disorder
  • Pregnant, breastfeeding or planning to conceive

Outcomes

Primary Outcomes

Is there a correlation between body site temperature and degree of fluorescence prior to and/or during PDT

Time Frame: 12months

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.

Secondary Outcomes

  • Is there a correlation between temperature and/or fluorescence and treatment outcome(12months)
  • phototoxicity (inflammation) measured immediately after irradiation(12months)
  • How does the spatial distribution of fluorescence and temperature change prior to and during PDT(12months)
  • Pain measured immediately after irradiation(12months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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