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

University of California Irvine (UCI)

Status and phase: Completed; Phase 1

Conditions: Signs and Symptoms; Skin Cancer

Treatments: Device: Modulated Imaging (MI); Other: Photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00784108

20086439

Details and patient eligibility

About

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 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

11 participants in 2 patient groups

Diagnostic tool

Other group

Description:

Modulated Imaging measure effect of Photodynamic therapy treatment

Treatment:

Device: Modulated Imaging (MI)

Photodynamic therapy

Other group

Description:

Modulated Imaging measure effect of Photodynamic therapy treatment

Treatment:

Other: Photodynamic therapy