Optical Device for Detection of Photosensitizer and Singlet Oxygen Levels in Patients with Actinic Keratoses Undergoing Photodynamic Therapy

Status: closed to accrual

This clinical trial tests a new video device which takes images of skin lesions during the treatment, to learn whether this device can predict how well the treatment is working in patients with actinic keratoses (skin lesions that have the potential to turn into skin cancer) who are undergoing red light photodynamic therapy (PDT). PDT is a technique that works by combining a photosensitizing topical agent aminolevulinic acid hydrochloride, (Levulan), and an intense light source to kill cancer cells. PDT has been used by dermatologists for over 20 years for treating skin cancer and precancer. While PDT is usually effective, it is still not possible to clear all lesions after a single treatment. Accumulated evidence shows widespread variability in the uptake and production of the photosensitizer molecule protoporphyrin IX (PpIX) within skin tumors, which could be an important factor to variable clinical outcomes. Singlet oxygen (sO2) is a highly-reactive molecule that is generated by excitation of PpIX during illumination which leads to cancer cell death, but has been very difficult or impossible to measure. Detection of sO2 would help determine how much Levulan is taken up into lesions and activated. A new optical device has been created to detect sO2 simply by taking a video of the skin during red light treatment. This study may help researchers learn whether this optical device can determine how much Levulan is taken up into lesions and activated to form sO2, how much sO2 is being produced during the treatment, and whether this can predict how well actinic keratoses respond after PDT.

Inclusion Criteria

Patients can be males of females of at least 18 years of age, with at least 10 AK lesions on the arms or legs, and with two AK lesions close enough to be seen together within a selected region of interest (ROI).
Female subjects must not become pregnant during the study. * The effects of 5-aminolevulinic acid (Levulan [trademark]) on the human fetus are unknown. For this reason, women of child-bearing potential must agree to use contraception. However, we note here that the vast majority of patients with chronic sun-induced AK lesions are beyond the age of menopause.
Subjects must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria

Pregnant or nursing.
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 OBJECTIVE:

I. To determine whether the rate of sO2 production, and/or the initial level of PpIX can predict clinical responsiveness of AK lesions to PDT treatment (lesion clearance at 3 months).

SECONDARY OBJECTIVES:

I. To characterize the variability in PpIX production and sO2 generation between similarly-sized lesions.

II. To test whether production of sO2 during PDT correlates with the amount of photosensitizer available in AK lesions.

OUTLINE:

Patients undergo baseline skin examination, counting, photography, and video recording of AK lesions, and identification of region of interest (ROI) on visit 1 of the study. Patients then undergo PpIX measurement from the ROI at baseline, apply aminolevulinic acid hydrochloride topically to the ROI and all other areas being treated covered with plastic wrap for 4 hours, and undergo additional PpIX and sO2 measurements from the ROI post-application. Patients undergo standard of care (SOC) red light PDT with continuous sO2 measurements from the ROI over 8-10 minutes and video recording of AK lesions before, during, and after PDT. Patients also undergo another PpIX measurement of the ROI post-PDT.

After completion of study, patients are followed up at 3-6 months after PDT treatment for repeat AK lesion assessment.

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Optical Device for Detection of Photosensitizer and Singlet Oxygen Levels in Patients with Actinic Keratoses Undergoing Photodynamic Therapy

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