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
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Signs and Symptoms
• Skin Cancer
• Skin Neoplasms

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