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.
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2008
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
November 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 1, 2022
October 1, 2022
3.9 years
October 30, 2008
October 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Measure tissue optical properties
Modulated Imaging measure effect of Photodynamic therapy treatment
4 weeks
Study Arms (2)
Diagnostic tool
OTHERModulated Imaging measure effect of Photodynamic therapy treatment
Photodynamic therapy
OTHERModulated Imaging measure effect of Photodynamic therapy treatment
Interventions
Modulated Imaging measure effect of Photodynamic therapy treatment
Modulated Imaging measure effect of Photodynamic therapy treatment
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Biopsy proven diagnosis of a basal cell carcinoma in a non-facial area
You may not qualify if:
- Age \< 18 years
- Pregnancy
- Breast feeding.
- photosensitivity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beckman Laser Institute Medical clinic
Irvine, California, 92612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristen M Kelly, MD
Beckman Laser Institute University of California Irvine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery
Study Record Dates
First Submitted
October 30, 2008
First Posted
November 3, 2008
Study Start
October 1, 2008
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
November 1, 2022
Record last verified: 2022-10