RECRUITING

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

Conditions

Actinic Keratoses Red Light Photodynamic Therapy Protoporphyrin IX

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Noninvasive Imaging Techniques to Monitor Photosensitizer and Singlet Oxygen Levels During Photodynamic Therapy of Actinic Keratoses

Quick Facts

Study Start:2024-08-25

Study Completion:2025-05-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05923060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Edward Maytin, MD, PhD

CONTACT

(216) 445-6676

maytine@ccf.org

Principal Investigator

Edward Maytin, MD, PhD

PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Case Comprehensive Cancer Center

Study Locations (Sites)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

Edward Maytin, MD, PhD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-25

Study Completion Date2025-05-22

Study Record Updates

Study Start Date2024-08-25

Study Completion Date2025-05-22

Terms related to this study

Keywords Provided by Researchers

Actinic Keratoses
Red Light
Photodynamic Therapy
Protoporphyrin IX

Additional Relevant MeSH Terms

Actinic Keratoses