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

Noninvasive Imaging Techniques to Monitor Photosensitizer and Singlet Oxygen Levels During Photodynamic Therapy of Actinic Keratoses

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Actinic Keratoses
• Intervention / Treatment: Drug: Topical Aminolevulinate; Procedure: Photodynamic therapy (PDT); Procedure: Red light illumination

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Edward Maytin, MD, PhD; Phone Number: (216) 445-6676; Email: maytine@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic, Case Comprehensive Cancer Center
      • Contact: Edward Maytin, MD, PhD; Phone Number: 216-445-6676; Email: maytine@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Drug: Topical Aminolevulinate; Topical Levulan Kerastick is applied to actinic keratoses.; Other Names: Levulan Kerastick; Levulan; Aminolevulinic Acid; Procedure: Photodynamic therapy (PDT); PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells.; Procedure: Red light illumination; To occur post-PTD; used for activation of ALA during photodynamic therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Clearance	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	3 months post PDT treatment.
Noninvasive optical measurements of photosensitizer (PpIX) in lesions	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.	3 months post PDT treatment.
Noninvasive optical measurements of singlet oxygen (sO2) in lesions.	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.	3 months post PDT treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noninvasive optical measurements variability of photosensitizer (PpIX) in lesions	To characterize the variability in PpIX production between similarly-sized lesions. This will be measured by the accumulation of PpIX.	3 months post PDT treatment.
Noninvasive optical measurements variability of singlet oxygen (sO2) in lesions	To characterize the variability in sO2 generation between similarly-sized lesions, and to test whether production of sO2 during PDT correlates with the amount of photosensitizer available in AK lesions. This will be measured by sO2 production, measured in real-time by sO2 dosimeter.	3 months post PDT treatment.

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Edward Maytin, MD, PhD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): May 22, 2025
• Study Completion (Estimated): May 22, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Photodynamic Therapy; Actinic Keratoses; Red Light; Protoporphyrin IX
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: CASE6622; R44CA250727 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in publication
• IPD Sharing Access Criteria: Cleveland Clinic will share de-identified optical digital code from the fluorescence instrument with Physical Sciences, Inc where it will be processed for final spectral analysis
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No