Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Enrolling; Phase 2

Conditions: Actinic Keratoses

Treatments: Procedure: Photodynamic therapy (PDT); Drug: Topical Aminolevulinate; Procedure: Red light illumination

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05923060

CASE6622

R44CA250727 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Female participants cannot be or become pregnant, nor can be nursing while on this study
• 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Standard PDT + topical aminolevulinate + red light illumination

Experimental group

Description:

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.

Treatment:

Procedure: Red light illumination

Procedure: Photodynamic therapy (PDT)

Drug: Topical Aminolevulinate