Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses
NCT ID: NCT05923060
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2024-08-25
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
Topical Aminolevulinate
Topical Levulan Kerastick is applied to actinic keratoses.
Photodynamic therapy (PDT)
PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells.
Red light illumination
To occur post-PTD; used for activation of ALA during photodynamic therapy.
Interventions
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Topical Aminolevulinate
Topical Levulan Kerastick is applied to actinic keratoses.
Photodynamic therapy (PDT)
PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells.
Red light illumination
To occur post-PTD; used for activation of ALA during photodynamic therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must be able to understand and are willing to sign a written informed consent document
Exclusion Criteria
* 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
* Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material
* Patients with history of a photosensitivity disease, such as porphyria cutanea tarda
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institutes of Health (NIH)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Edward Maytin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic, Case Comprehensive Cancer Center
Locations
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Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CASE6622
Identifier Type: -
Identifier Source: org_study_id
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