Optimizing Photodynamic Therapy of Cutaneous Neoplastic Diseases Via Structured Illumination and Real-time Dosimetry.
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Purpose
The purpose of this study is to determine if a novel, unique, non-contact optical imaging device(camera) developed at the Beckman Laser Institute (BLI), called Modulated Imaging (MI), can help us customize Photodynamic therapy (PDT) treatment for patients with skin cancer. The device developed will be used to measure tissue optical properties that effect the PDT treatment process (e.g. spectral absorption and scattering coefficients, oxy- and deoxy-hemoglobin, water, melanin) and use that information to provide customized laser light treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Skin Cancer |
Device: Modulated Imaging (MI) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Non-contact Imaging Device (Camera) Can Help Improve Treatment for Patients With Basal Cell Carcinoma. |
- To determine if non-contact optical imaging device called Modulated Imaging (MI), can help us customize PDT treatment for patients with skin cancer. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 11 |
| Study Start Date: | October 2008 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| PDT/MI |
Device: Modulated Imaging (MI)
skin imaging
Other Name: non-contact optical imaging device (camera)
|
Detailed Description:
The current standard of care for skin cancer is excision, curettage and electrodesiccation and/or cryosurgery. These methods result in scarring, whereas PDT, on the other hand, offers the potential for enhanced treatment with less scarring. In spite of this advantage that PDT has over current techniques, it has still not achieved the consistent performance required to gain clinical acceptance.
The researchers want to 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Beckman Laser Institute Medical clinic | |
| Irvine, California, United States, 92612 | |
| Principal Investigator: | Kristen M Kelly, MD | Beckman Laser Institute University of California Irvine |
More Information
No publications provided
| Responsible Party: | Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00784108 History of Changes |
| Other Study ID Numbers: | LAMMP-NIH- |
| Study First Received: | October 30, 2008 |
| Last Updated: | December 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Skin Neoplasms Neoplasms by Site Neoplasms Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013