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

October 30, 2008
December 26, 2012
October 2008
September 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
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 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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Skin Cancer
Device: Modulated Imaging (MI)
skin imaging
Other Name: non-contact optical imaging device (camera)
PDT/MI
Intervention: Device: Modulated Imaging (MI)
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
LAMMP-NIH-
Yes
Montana Compton, University of California, Irvine
Montana Compton
Not Provided
Principal Investigator: Kristen M Kelly, MD Beckman Laser Institute University of California Irvine
University of California, Irvine
December 2012

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