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

Phase 1

Completed

• Conditions: Skin Cancer; Signs and Symptoms
• Interventions: Device: Modulated Imaging (MI); Other: Photodynamic therapy

• Registration Number: NCT00784108
• Lead Sponsor: University of California, Irvine

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-11-02
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic tool	Modulated Imaging (MI)	Modulated Imaging measure effect of Photodynamic therapy treatment
Photodynamic therapy	Photodynamic therapy	Modulated Imaging measure effect of Photodynamic therapy treatment

Primary Outcome Measures

Name	Time	Method
Measure tissue optical properties	4 weeks	Modulated Imaging measure effect of Photodynamic therapy treatment

Trial Locations

Locations (1)

Beckman Laser Institute Medical clinic; 🇺🇸 Irvine, California, United States