Using imaging to monitor treatment of skin lesions caused by sun damage
Noninvasive Imaging Techniques to Monitor Photosensitizer and Singlet Oxygen Levels During Photodynamic Therapy of Actinic Keratoses
This study is testing a new imaging device to see if it can help track how well photodynamic therapy works for people with sun-damaged skin lesions called actinic keratoses.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05923060 on ClinicalTrials.gov |
What this trial studies
This study tests a new video device that captures images of actinic keratoses during photodynamic therapy (PDT) to assess treatment effectiveness. Participants will receive standard PDT with red light while their lesions are monitored through imaging to evaluate the production of singlet oxygen and photosensitizer levels. The goal is to determine if these measurements can predict how well the treatment works. The study aims to improve treatment strategies for actinic keratoses by establishing optimal conditions for PDT.
Who should consider this trial
Good fit: Ideal candidates are individuals with at least 10 actinic keratoses lesions on their arms or legs.
Not a fit: Patients who are pregnant, nursing, or have a history of photosensitivity diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatments for actinic keratoses, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using imaging techniques to enhance treatment monitoring, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Edward Maytin, MD, PhD — Cleveland Clinic, Case Comprehensive Cancer Center
- Study coordinator: Edward Maytin, MD, PhD
- Email: maytine@ccf.org
- Phone: (216) 445-6676
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.