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

Overview

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.

Full Title of Study: “Non-contact Imaging Device (Camera) Can Help Improve Treatment for Patients With Basal Cell Carcinoma.”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Supportive Care
  • Masking: Single (Outcomes Assessor)
• Study Primary Completion Date: September 2012

Detailed Description

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.

Interventions

• Device: Modulated Imaging (MI)
  • Modulated Imaging measure effect of Photodynamic therapy treatment
• Other: Photodynamic therapy
  • Modulated Imaging measure effect of Photodynamic therapy treatment

Arms, Groups and Cohorts

• Other: Diagnostic tool
  • Modulated Imaging measure effect of Photodynamic therapy treatment
• Other: Photodynamic therapy
  • Modulated Imaging measure effect of Photodynamic therapy treatment

Clinical Trial Outcome Measures

Primary Measures

• Measure tissue optical properties
  • Time Frame: 4 weeks
  • Modulated Imaging measure effect of Photodynamic therapy treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of California, Irvine
• Collaborator
  • Beckman Laser Institute University of California Irvine
• Provider of Information About this Clinical Study
  • Principal Investigator: Beckman Laser Institute and Medical Center, Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery – University of California, Irvine
• Overall Official(s)
  • Kristen M Kelly, MD, Principal Investigator, Beckman Laser Institute University of California Irvine