Optimizing Photodynamic Therapy of Cutaneous Neoplastic Diseases Via Structured Illumination and Real-time Dosimetry.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate native tissue optical properties and photosensitizer optical properties in vivo with a novel, non-contact optical imaging device call Modulated Imaging to help optimize the laser exposure in future photodynamic treatment for patients with skin cancer. Photodynamic therapy involves the administration of a tumor-localizing photosensitizing agent that, when illuminated with the proper wavelength of light, can result in photochemical processes that cause irreversible damage to tumor tissues. Photodynamic therapy is non-invasive and has been shown to be effective in the treatment of skin cancer while producing excellent aesthetic appearance and psychological well-being in patients that normally would require invasive excisions.

Detailed Description
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The current standard of care for skin cancer is excision, curettage and electrodesiccation and/or cryosurgery. The Modulated Imaging can measure tissue optical properties that effect the Photodynamic therapy treatment process can show spectral absorption and scattering coefficients, oxy- and deoxy-hemoglobin, water, melanin and use that information to provide customized laser light treatment. The researchers can use an imaging system that can characterize the tissue and photosensitizer optical properties and use that information to drive a treatment light projection system that can spatially optimize the light irradiance for personalized treatment, thus improving outcomes.

Official Title
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Non-contact Imaging Device (Camera) Can Help Improve Treatment for Patients With Basal Cell Carcinoma.

Conditions
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Skin Cancer, Signs and Symptoms

Intervention / Treatment
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* Device: Modulated Imaging (MI)
* Other: Photodynamic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Biopsy proven diagnosis of a basal cell carcinoma in a non-facial area Exclusion Criteria: Age < 18 years Pregnancy Breast feeding. photosensitivity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diagnostic tool<br>Modulated Imaging measure effect of Photodynamic therapy treatment | Device: Modulated Imaging (MI)<br>* Modulated Imaging measure effect of Photodynamic therapy treatment<br>* Other names: non-contact optical imaging device (camera);|
| Other: Photodynamic therapy<br>Modulated Imaging measure effect of Photodynamic therapy treatment | Other: Photodynamic therapy<br>* Modulated Imaging measure effect of Photodynamic therapy treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure tissue optical properties | Modulated Imaging measure effect of Photodynamic therapy treatment | 4 weeks |