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

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00784108
First received: October 30, 2008
Last updated: June 10, 2015
Last verified: June 2015

October 30, 2008
June 10, 2015
October 2008
September 2012   (final data collection date for primary outcome measure)
Measure tissue optical properties [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Modulated Imaging measure effect of Photodynamic therapy treatment
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 ]
Complete list of historical versions of study NCT00784108 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Skin Cancer
  • Signs and Symptoms
  • Device: Modulated Imaging (MI)
    Modulated Imaging measure effect of Photodynamic therapy treatment
    Other Name: non-contact optical imaging device (camera)
  • Other: Photodynamic therapy
    Modulated Imaging measure effect of Photodynamic therapy treatment
  • Diagnostic tool
    Modulated Imaging measure effect of Photodynamic therapy treatment
    Intervention: Device: Modulated Imaging (MI)
  • Photodynamic therapy
    Modulated Imaging measure effect of Photodynamic therapy treatment
    Intervention: Other: Photodynamic therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00784108
NIH-LAMMP-2008-6439
Yes
Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
Beckman Laser Institute University of California Irvine
Principal Investigator: Kristen M Kelly, MD Beckman Laser Institute University of California Irvine
University of California, Irvine
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP