Overview

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

Status:
Not yet recruiting
Trial end date:
2025-05-22
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Treatments:
Aminolevulinic Acid
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