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

NCT ID: NCT00784108

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Skin Cancer Signs and Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diagnostic tool

Modulated Imaging measure effect of Photodynamic therapy treatment

Group Type OTHER

Modulated Imaging (MI)

Intervention Type DEVICE

Modulated Imaging measure effect of Photodynamic therapy treatment

Photodynamic therapy

Modulated Imaging measure effect of Photodynamic therapy treatment

Group Type OTHER

Photodynamic therapy

Intervention Type OTHER

Modulated Imaging measure effect of Photodynamic therapy treatment

Interventions

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Modulated Imaging (MI)

Modulated Imaging measure effect of Photodynamic therapy treatment

Intervention Type DEVICE

Photodynamic therapy

Modulated Imaging measure effect of Photodynamic therapy treatment

Intervention Type OTHER

Other Intervention Names

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non-contact optical imaging device (camera)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristen M Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Locations

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Beckman Laser Institute Medical clinic

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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20086439

Identifier Type: -

Identifier Source: org_study_id

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