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NCT00784108 Clinical Trial

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

Skin Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00784108
Other study ID # 20086439
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2008
Est. completion date September 2012

Study information
Verified date October 2022
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Beckman Laser Institute Medical clinic Irvine California

Sponsors (2)
Lead Sponsor Collaborator
University of California, Irvine Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure tissue optical properties Modulated Imaging measure effect of Photodynamic therapy treatment 4 weeks
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