Noninvasive Imaging Techniques to Monitor Photosensitizer and Singlet Oxygen Levels During Photodynamic Therapy of Actinic Keratoses
Overview
- Phase
- Phase 2
- Intervention
- Topical Aminolevulinate
- Conditions
- Actinic Keratoses
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Lesion Clearance
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
The purpose of the study is to test a new video device for actinic keratoses. The device takes images of your skin lesions during the treatment, to learn whether this device can predict how well the treatment is working.
Detailed Description
This intervention is designed to help establish what the optimal conditions are for treating actinic keratoses with photodynamic therapy (PDT). The primary outcome of this study is to determine whether the rate of singlet oxygen (sO2) production and/or the initial intralesional photosensitize (PpIX) levels, can predict the clinical responsiveness of AK lesions to PDT. Participants will receive standard red light PDT treatment, except that lesions will be carefully counted beforehand. During the window of red light illumination, photos and a video of one area of skin will be taken to allow us to monitor the progress of the treatment. Any remaining lesions will be counted upon follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants of at least 18 years of age, with at least 10 AK lesions on the arms or legs, and with two AK lesions close enough to be seen together within a selected region of interest.
- •Female participants must not become pregnant during the study. The effects of 5-aminolevulinic acid (LevulanTM) on the human fetus are unknown. For this reason, participants of child-bearing potential must agree to use contraception. However, we note here that the vast majority of participants with chronic sun-induced AK lesions are beyond the age of menopause.
- •Participants must be able to understand and willing to sign a written informed consent document.
Exclusion Criteria
- •Pregnant or nursing.
- •Using any topical treatment on their AKs; must stop at least one month prior.
- •Currently undergoing treatment for other cancers with medical or radiation therapy.
- •Participants with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
- •Participants with history of a photosensitivity disease, such as porphyria cutanea tarda.
Arms & Interventions
Standard PDT + topical aminolevulinate + red light illumination
Standard PDT using topical aminolevulinate followed by red light illumination for actinic keratosis. A region of interest (ROI) on the skin of the arms, hands, legs, or feet will be selected for monitoring. This ROI will be marked and baseline measurements will be taken. The topical drug Levulan (ALA) will be applied to the ROI and other areas being treated, and covered with plastic wrap. Prior to red light illumination, post topical measurements and baseline values will be performed to measure PpIX and sO2. Red light illumination will follow, and sO2 phosphorescence will be recorded continuously from the ROI. After, a post-PpIX measurement will be taken.
Intervention: Topical Aminolevulinate
Standard PDT + topical aminolevulinate + red light illumination
Standard PDT using topical aminolevulinate followed by red light illumination for actinic keratosis. A region of interest (ROI) on the skin of the arms, hands, legs, or feet will be selected for monitoring. This ROI will be marked and baseline measurements will be taken. The topical drug Levulan (ALA) will be applied to the ROI and other areas being treated, and covered with plastic wrap. Prior to red light illumination, post topical measurements and baseline values will be performed to measure PpIX and sO2. Red light illumination will follow, and sO2 phosphorescence will be recorded continuously from the ROI. After, a post-PpIX measurement will be taken.
Intervention: Photodynamic therapy (PDT)
Standard PDT + topical aminolevulinate + red light illumination
Standard PDT using topical aminolevulinate followed by red light illumination for actinic keratosis. A region of interest (ROI) on the skin of the arms, hands, legs, or feet will be selected for monitoring. This ROI will be marked and baseline measurements will be taken. The topical drug Levulan (ALA) will be applied to the ROI and other areas being treated, and covered with plastic wrap. Prior to red light illumination, post topical measurements and baseline values will be performed to measure PpIX and sO2. Red light illumination will follow, and sO2 phosphorescence will be recorded continuously from the ROI. After, a post-PpIX measurement will be taken.
Intervention: Red light illumination
Outcomes
Primary Outcomes
Lesion Clearance
Time Frame: 3 months post PDT treatment.
Based on the rate of sO2 production, and/or the initial level of PpIX, is significantly correlated with the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the decrease in the number of lesions
Noninvasive optical measurements of singlet oxygen (sO2) in lesions.
Time Frame: 3 months post PDT treatment.
To determine whether the rate of sO2 production can predict the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the change in sO2 value before and after red light illumination.
Noninvasive optical measurements of photosensitizer (PpIX) in lesions
Time Frame: 3 months post PDT treatment.
To determine whether the initial level of PpIX can predict the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the change in PpIX value before and after red light illumination.
Secondary Outcomes
- Noninvasive optical measurements variability of singlet oxygen (sO2) in lesions(3 months post PDT treatment.)
- Noninvasive optical measurements variability of photosensitizer (PpIX) in lesions(3 months post PDT treatment.)