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

Launched by CASE COMPREHENSIVE CANCER CENTER · Jun 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new video device designed to help monitor skin lesions called actinic keratoses during a specific treatment known as photodynamic therapy. The goal is to see if this device can help doctors predict how effective the treatment is by taking images of the lesions on your skin while the treatment is happening.

To participate in the trial, you need to have at least 10 actinic keratoses lesions on your arms or legs, with two of them close enough together to be seen in the same picture. It's important that you understand and agree to the study by signing a consent form. However, if you are pregnant, nursing, or using certain treatments for other cancers or skin conditions, you may not be eligible to join. If you decide to participate, you can expect to have your skin lesions photographed during the treatment, which will help researchers learn more about the effectiveness of this new monitoring device.

Gender

ALL

Eligibility criteria

• 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