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

Primary Purpose

Skin Cancer, Signs and Symptoms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Modulated Imaging (MI)
Photodynamic therapy
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Skin Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beckman Laser Institute Medical clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Diagnostic tool

Photodynamic therapy

Arm Description

Modulated Imaging measure effect of Photodynamic therapy treatment

Modulated Imaging measure effect of Photodynamic therapy treatment

Outcomes

Primary Outcome Measures

Measure tissue optical properties
Modulated Imaging measure effect of Photodynamic therapy treatment

Secondary Outcome Measures

Full Information

First Posted
October 30, 2008
Last Updated
October 28, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT00784108
Brief Title
Optimizing Photodynamic Therapy of Cutaneous Neoplastic Diseases Via Structured Illumination and Real-time Dosimetry.
Official Title
Non-contact Imaging Device (Camera) Can Help Improve Treatment for Patients With Basal Cell Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer, Signs and Symptoms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic tool
Arm Type
Other
Arm Description
Modulated Imaging measure effect of Photodynamic therapy treatment
Arm Title
Photodynamic therapy
Arm Type
Other
Arm Description
Modulated Imaging measure effect of Photodynamic therapy treatment
Intervention Type
Device
Intervention Name(s)
Modulated Imaging (MI)
Other Intervention Name(s)
non-contact optical imaging device (camera)
Intervention Description
Modulated Imaging measure effect of Photodynamic therapy treatment
Intervention Type
Other
Intervention Name(s)
Photodynamic therapy
Intervention Description
Modulated Imaging measure effect of Photodynamic therapy treatment
Primary Outcome Measure Information:
Title
Measure tissue optical properties
Description
Modulated Imaging measure effect of Photodynamic therapy treatment
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen M Kelly, MD
Organizational Affiliation
Beckman Laser Institute University of California Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute Medical clinic
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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