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

Actinic Keratoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05923060
• Other study ID #: CASE6622
• Secondary ID: R44CA250727
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2024
• Est. completion date: May 22, 2025

Study information

• Verified date: May 2024
• Source: Case Comprehensive Cancer Center
• Contact: Edward Maytin, MD, PhD
• Phone: (216) 445-6676
• Email: maytine[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 22, 2025
• Est. primary completion date: May 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Topical Aminolevulinate
Topical Levulan Kerastick is applied to actinic keratoses.

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.