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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00784108
First received: October 30, 2008
Last updated: December 26, 2012
Last verified: December 2012
  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.

Resource links provided by NLM:


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 ]

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
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
Montana Compton
Investigators
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

ClinicalTrials.gov processed this record on October 20, 2014