- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00784108
Optimizing Photodynamic Therapy of Cutaneous Neoplastic Diseases Via Structured Illumination and Real-time Dosimetry.
Non-contact Imaging Device (Camera) Can Help Improve Treatment for Patients With Basal Cell Carcinoma.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Irvine, California, United States, 92612
- Beckman Laser Institute Medical Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Diagnostic tool
Modulated Imaging measure effect of Photodynamic therapy treatment
|
Modulated Imaging measure effect of Photodynamic therapy treatment
Other Names:
|
Other: Photodynamic therapy
Modulated Imaging measure effect of Photodynamic therapy treatment
|
Modulated Imaging measure effect of Photodynamic therapy treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure tissue optical properties
Time Frame: 4 weeks
|
Modulated Imaging measure effect of Photodynamic therapy treatment
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kristen M Kelly, MD, Beckman Laser Institute University of California Irvine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20086439
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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