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
  Purpose

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 Intervention Phase
Skin Cancer
Signs and Symptoms
Device: Modulated Imaging (MI)
Other: Photodynamic therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Measure tissue optical properties [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Modulated Imaging measure effect of Photodynamic therapy treatment


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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Kristen M Kelly, MD Beckman Laser Institute University of California Irvine
  More Information

No publications 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     History of Changes
Other Study ID Numbers: NIH-LAMMP-2008-6439
Study First Received: October 30, 2008
Last Updated: June 10, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2015