Clinical trial NCT05923060: Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses
Official title: Noninvasive Imaging Techniques to Monitor Photosensitizer and Singlet Oxygen Levels During Photodynamic Therapy of Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Actinic Keratoses
Keywords: Actinic Keratoses
Red Light
Photodynamic Therapy
Protoporphyrin IX
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2023-06-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

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

Primary outcomes:
measure: Lesion Clearance
timeFrame: 3 months post PDT treatment.
measure: Noninvasive optical measurements of photosensitizer (PpIX) in lesions
timeFrame: 3 months post PDT treatment.
measure: Noninvasive optical measurements of singlet oxygen (sO2) in lesions.
timeFrame: 3 months post PDT treatment.
Secondary outcomes:
measure: Noninvasive optical measurements variability of photosensitizer (PpIX) in lesions
timeFrame: 3 months post PDT treatment.
measure: Noninvasive optical measurements variability of singlet oxygen (sO2) in lesions
timeFrame: 3 months post PDT treatment.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Edward Maytin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: