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Optimizing Photodynamic Therapy of Cutaneous Neoplastic Diseases Via Structured Illumination and Real-time Dosimetry.

Sponsor
University of California, Irvine (Other)
Overall Status
Completed
CT.gov ID
NCT00784108
Collaborator
Beckman Laser Institute University of California Irvine (Other)
11
Enrollment
1
Location
2
Arms
47
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Modulated Imaging (MI)
  • Other: Photodynamic therapy
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Non-contact Imaging Device (Camera) Can Help Improve Treatment for Patients With Basal Cell Carcinoma.
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Other: Diagnostic tool

Modulated Imaging measure effect of Photodynamic therapy treatment

Device: Modulated Imaging (MI)
Modulated Imaging measure effect of Photodynamic therapy treatment
Other Names:
  • non-contact optical imaging device (camera)

    		•
    Other: Photodynamic therapy

    Modulated Imaging measure effect of Photodynamic therapy treatment

    Other: Photodynamic therapy
    Modulated Imaging measure effect of Photodynamic therapy treatment

    Outcome Measures

    Primary Outcome Measures

    1. Measure tissue optical properties [4 weeks]

      Modulated Imaging measure effect of Photodynamic therapy treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Beckman Laser Institute Medical clinic Irvine California United States 92612

    Sponsors and Collaborators

    • University of California, Irvine
    • Beckman Laser Institute University of California Irvine

    Investigators

    • Principal Investigator: Kristen M Kelly, MD, Beckman Laser Institute University of California Irvine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beckman Laser Institute and Medical Center, Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery, University of California, Irvine
    ClinicalTrials.gov Identifier:
    NCT00784108
    Other Study ID Numbers:
    • NIH-LAMMP-2008-6439
    First Posted:
    Nov 2, 2008
    Last Update Posted:
    Feb 10, 2017
    Last Verified:
    Feb 1, 2017
    Additional relevant MeSH terms:
    Skin Neoplasms

    Study Results

    No Results Posted as of Feb 10, 2017