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NCT05923060 | RECRUITING | Actinic Keratoses

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

Case Comprehensive Cancer Center

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.

Condition or disease

Actinic Keratoses

Intervention/treatment

Topical Aminolevulinate

Photodynamic therapy (PDT)

Red light illumination

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Noninvasive Imaging Techniques to Monitor Photosensitizer and Singlet Oxygen Levels During Photodynamic Therapy of Actinic Keratoses
Actual Study Start Date : 2024-08-25
Estimated Primary Completion Date : 2025-05-22
Estimated Study Completion Date : 2025-05-22

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses

Location Details

NCT05923060

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Ohio

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44195