Optimizing Photodynamic Therapy of Cutaneous Neoplastic Diseases Via Structured Illumination and Real-Time Dosimetry. - Full Text View

Sponsors and Collaborators:	University of California, Irvine Department of Defense
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00784108

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 I

MedlinePlus related topics: Cancer Skin Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study
Official Title:	Non-Contact Imaging Device (Camera) Can Help Improve Treatment for Patients With Basal Cell Carcinoma.

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PDT/MI: Experimental	Device: Modulated Imaging (MI) skin imaging

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784108

Locations

United States, California
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612

Sponsors and Collaborators

University of California, Irvine

Department of Defense

Investigators

Principal Investigator:

Kristen M Kelly, MD

Beckman Laser Institute University of California Irvine

More Information

Responsible Party:	Beckman Laser Institute ( Kristen Kelly, MD )
Study ID Numbers:	DOD-W81XWH-08-1-008, TATRC
Study First Received:	October 30, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00784108
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases
Carcinoma, Basal Cell
Skin Neoplasms
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009