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Photographing the Skin During Photodynamic Therapy

Primary Purpose

Basal Cell Carcinoma, Bowen's Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fluorescence and thermal imaging
Sponsored by
University of Dundee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Basal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ninewells Hopsital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 22, 2017
Last Updated
July 15, 2021
Sponsor
University of Dundee
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1. Study Identification

Unique Protocol Identification Number
NCT03167762
Brief Title
Photographing the Skin During Photodynamic Therapy
Official Title
Fluorescence and Thermal Imaging of the Skin Before and During Photodynamic Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 22, 2017 (Actual)
Primary Completion Date
June 22, 2020 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Dundee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Bowen's Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fluorescence and thermal imaging
Intervention Description
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
Primary Outcome Measure Information:
Title
Is there a correlation between body site temperature and degree of fluorescence prior to and/or during PDT
Description
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.
Time Frame
12months
Secondary Outcome Measure Information:
Title
Is there a correlation between temperature and/or fluorescence and treatment outcome
Description
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.
Time Frame
12months
Title
How does the spatial distribution of fluorescence and temperature change prior to and during PDT
Description
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.
Time Frame
12months
Title
Pain measured immediately after irradiation
Description
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.
Time Frame
12months
Title
phototoxicity (inflammation) measured immediately after irradiation
Description
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.
Time Frame
12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ninewells Hopsital
City
Dundee
State/Province
Tayside
ZIP/Postal Code
dd1 9sy
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18945319
Citation
Morton CA, McKenna KE, Rhodes LE; British Association of Dermatologists Therapy Guidelines and Audit Subcommittee and the British Photodermatology Group. Guidelines for topical photodynamic therapy: update. Br J Dermatol. 2008 Dec;159(6):1245-66. doi: 10.1111/j.1365-2133.2008.08882.x. Epub 2008 Oct 13.
Results Reference
background
PubMed Identifier
23181594
Citation
Morton CA, Szeimies RM, Sidoroff A, Braathen LR. European guidelines for topical photodynamic therapy part 1: treatment delivery and current indications - actinic keratoses, Bowen's disease, basal cell carcinoma. J Eur Acad Dermatol Venereol. 2013 May;27(5):536-44. doi: 10.1111/jdv.12031. Epub 2012 Nov 26.
Results Reference
background
PubMed Identifier
23128146
Citation
Valentine RM, Ibbotson SH, Wood K, Brown CT, Moseley H. Modelling fluorescence in clinical photodynamic therapy. Photochem Photobiol Sci. 2013 Jan;12(1):203-13. doi: 10.1039/c2pp25271f.
Results Reference
background
PubMed Identifier
26931503
Citation
Mamalis A, Koo E, Sckisel GD, Siegel DM, Jagdeo J. Temperature-dependent impact of thermal aminolaevulinic acid photodynamic therapy on apoptosis and reactive oxygen species generation in human dermal fibroblasts. Br J Dermatol. 2016 Sep;175(3):512-9. doi: 10.1111/bjd.14509. Epub 2016 Jul 24.
Results Reference
background
PubMed Identifier
26467274
Citation
Kulyk O, Ibbotson SH, Moseley H, Valentine RM, Samuel ID. Development of a handheld fluorescence imaging device to investigate the characteristics of protoporphyrin IX fluorescence in healthy and diseased skin. Photodiagnosis Photodyn Ther. 2015 Dec;12(4):630-9. doi: 10.1016/j.pdpdt.2015.10.002. Epub 2015 Oct 20.
Results Reference
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Photographing the Skin During Photodynamic Therapy

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