Back to resultsImaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses
Primary Purpose
Actinic Keratoses
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topical Aminolevulinate
Photodynamic therapy (PDT)
Red light illumination
Sponsored by
About this trial
This is an interventional prevention trial for Actinic Keratoses focused on measuring Actinic Keratoses, Red Light, Photodynamic Therapy, Protoporphyrin IX
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
Sites / Locations
- Cleveland Clinic, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Standard PDT + topical aminolevulinate + red light illumination
Arm Description
Standard PDT using topical aminolevulinate followed by red light illumination for actinic keratosis. A region of interest (ROI) on the skin of the arms, hands, legs, or feet will be selected for monitoring. This ROI will be marked and baseline measurements will be taken. The topical drug Levulan (ALA) will be applied to the ROI and other areas being treated, and covered with plastic wrap. Prior to red light illumination, post topical measurements and baseline values will be performed to measure PpIX and sO2. Red light illumination will follow, and sO2 phosphorescence will be recorded continuously from the ROI. After, a post-PpIX measurement will be taken.
Outcomes
Primary Outcome Measures
Lesion Clearance
Based on the rate of sO2 production, and/or the initial level of PpIX, is significantly correlated with the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the decrease in the number of lesions
Noninvasive optical measurements of photosensitizer (PpIX) in lesions
To determine whether the initial level of PpIX can predict the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the change in PpIX value before and after red light illumination.
Noninvasive optical measurements of singlet oxygen (sO2) in lesions.
To determine whether the rate of sO2 production can predict the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the change in sO2 value before and after red light illumination.
Secondary Outcome Measures
Noninvasive optical measurements variability of photosensitizer (PpIX) in lesions
To characterize the variability in PpIX production between similarly-sized lesions. This will be measured by the accumulation of PpIX.
Noninvasive optical measurements variability of singlet oxygen (sO2) in lesions
To characterize the variability in sO2 generation between similarly-sized lesions, and to test whether production of sO2 during PDT correlates with the amount of photosensitizer available in AK lesions. This will be measured by sO2 production, measured in real-time by sO2 dosimeter.
Full Information
NCT ID
NCT05923060
First Posted
June 20, 2023
Last Updated
July 24, 2023
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05923060
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
May 22, 2025 (Anticipated)
Study Completion Date
May 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
Keywords
Actinic Keratoses, Red Light, Photodynamic Therapy, Protoporphyrin IX
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard PDT + topical aminolevulinate + red light illumination
Arm Type
Experimental
Arm Description
Standard PDT using topical aminolevulinate followed by red light illumination for actinic keratosis. A region of interest (ROI) on the skin of the arms, hands, legs, or feet will be selected for monitoring. This ROI will be marked and baseline measurements will be taken. The topical drug Levulan (ALA) will be applied to the ROI and other areas being treated, and covered with plastic wrap. Prior to red light illumination, post topical measurements and baseline values will be performed to measure PpIX and sO2. Red light illumination will follow, and sO2 phosphorescence will be recorded continuously from the ROI. After, a post-PpIX measurement will be taken.
Intervention Type
Drug
Intervention Name(s)
Topical Aminolevulinate
Other Intervention Name(s)
Levulan Kerastick, Aminolevulinic Acid, Levulan
Intervention Description
Topical Levulan Kerastick is applied to actinic keratoses.
Intervention Type
Procedure
Intervention Name(s)
Photodynamic therapy (PDT)
Intervention Description
PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells.
Intervention Type
Procedure
Intervention Name(s)
Red light illumination
Intervention Description
To occur post-PTD; used for activation of ALA during photodynamic therapy.
Primary Outcome Measure Information:
Title
Lesion Clearance
Description
Based on the rate of sO2 production, and/or the initial level of PpIX, is significantly correlated with the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the decrease in the number of lesions
Time Frame
3 months post PDT treatment.
Title
Noninvasive optical measurements of photosensitizer (PpIX) in lesions
Description
To determine whether the initial level of PpIX can predict the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the change in PpIX value before and after red light illumination.
Time Frame
3 months post PDT treatment.
Title
Noninvasive optical measurements of singlet oxygen (sO2) in lesions.
Description
To determine whether the rate of sO2 production can predict the clinical responsiveness of AK lesions to PDT treatment. The clinical responsiveness will be measured by the change in sO2 value before and after red light illumination.
Time Frame
3 months post PDT treatment.
Secondary Outcome Measure Information:
Title
Noninvasive optical measurements variability of photosensitizer (PpIX) in lesions
Description
To characterize the variability in PpIX production between similarly-sized lesions. This will be measured by the accumulation of PpIX.
Time Frame
3 months post PDT treatment.
Title
Noninvasive optical measurements variability of singlet oxygen (sO2) in lesions
Description
To characterize the variability in sO2 generation between similarly-sized lesions, and to test whether production of sO2 during PDT correlates with the amount of photosensitizer available in AK lesions. This will be measured by sO2 production, measured in real-time by sO2 dosimeter.
Time Frame
3 months post PDT treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward Maytin, MD, PhD
Phone
(216) 445-6676
Email
maytine@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Maytin, MD, PhD
Organizational Affiliation
Cleveland Clinic, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Maytin, MD, PhD
Phone
216-445-6676
Email
maytine@ccf.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in publication
IPD Sharing Access Criteria
Cleveland Clinic will share de-identified optical digital code from the fluorescence instrument with Physical Sciences, Inc where it will be processed for final spectral analysis
Learn more about this trial
Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses
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