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Trial Title:
Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses
NCT ID:
NCT05923060
Condition:
Actinic Keratoses
Conditions: Official terms:
Keratosis, Actinic
Keratosis
Aminolevulinic Acid
Conditions: Keywords:
Actinic Keratoses
Red Light
Photodynamic Therapy
Protoporphyrin IX
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Topical Aminolevulinate
Description:
Topical Levulan Kerastick is applied to actinic keratoses.
Arm group label:
Standard PDT + topical aminolevulinate + red light illumination
Other name:
Levulan Kerastick
Other name:
Aminolevulinic Acid
Other name:
Levulan
Intervention type:
Procedure
Intervention name:
Photodynamic therapy (PDT)
Description:
PDT is a technique that combines a photosensitizing drug and an intense light source to
kill tumor cells.
Arm group label:
Standard PDT + topical aminolevulinate + red light illumination
Intervention type:
Procedure
Intervention name:
Red light illumination
Description:
To occur post-PTD; used for activation of ALA during photodynamic therapy.
Arm group label:
Standard PDT + topical aminolevulinate + red light illumination
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cleveland Clinic, Case Comprehensive Cancer Center
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Edward Maytin, MD, PhD
Phone:
216-445-6676
Email:
maytine@ccf.org
Start date:
August 25, 2024
Completion date:
May 22, 2025
Lead sponsor:
Agency:
Case Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Source:
Case Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05923060
