Noninvasive Imaging Techniques to Monitor Photosensitizer and Singlet Oxygen Levels During Photodynamic Therapy of Actinic Keratoses
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants who have at least 10 Actinic Keratoses lesions on the arms of legs, and with two AK lesions close enough to be seen together within a selected region of interest (ROI)
• Participants must be able to understand and are willing to sign a written informed consent document
Locations
United States
Ohio
Cleveland Clinic, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Edward Maytin, MD, PhD
maytine@ccf.org
(216) 445-6676
Time Frame
Start Date: 2024-08-25
Estimated Completion Date: 2026-01
Participants
Target number of participants: 20
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Case Comprehensive Cancer Center
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)