Optical Sensor for Photodynamic Detection of Oral Pathology - Full Text View

Purpose

At Beckman Laser Institute, University of California, Irvine, we have developed diagnostic device call frequency-domain photon migration(FDPM and Optical Coherence tomography (OCT).

OCT is an imaging technique capable of performing high-resolution,cross-sectional imaging. OCT enables real-time, in situ visualization of tissue microstructure without the need to excise and process the specimen as required for conventional biopsy and histopathology.

FDPM technique measured in vivo using the the wavelength-dependent behavior of absorption and scattering.

Absorption measurements determine the water concentration, oxyhemoglobin concentration, deoxyhemoglobin concentration,total hemoglobin concentration, oxygen saturation, and fat percentage.
Scattering measurements determine the cell volume fraction,average cell size, and tissue structural heterogeneity.

Condition	Intervention
Oral Diseaes Abnormal Oral Mucosa	Device: OCT/DOS

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Optical Sensor for Photodynamic Detection of Oral Pathology

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	84
Study Start Date:	April 2003
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Device: OCT/DOS OCT/Diffuse Optical Spectroscopy

Detailed Description:

This study determined the change in the optical properties of oral tissues, and combine these with conventional semiquantitative histopathological to have information of the oral pathology.

The study to determine the absorption and reflection spectra of healthy and pathological oral tissues and to correlate these with oral pathology. Rationale is that tissue architecture, components, metabolic processes and vasculature change with the onset and progression of pathology. Each of these factors has optical signatures that detected non-invasively.

A soft small fiberoptic pen shape sensor with fiberoptic-based spectrographic system place in selective oral cavity. Six measurements and image will be taking within approximate 5 minutes.

The possible risks and/or discomforts associated with the procedures described in this study include some discomfort of having the optical tool placed in the mouth the device will be removed immediately. There may also be risks to participating that are currently unforeseeable.

There are no direct benefit but potential benefit to society by helping to develop new tools for early detection, monitoring, screening for oral pathology

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic, community sample

Criteria

Inclusion Criteria:

Male or Female age 18 years and older

Exclusion Criteria:

Age less than 18 years old

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540774

Locations


United States, California
	Beckman Laser Institute, University of California Irvine
	Irvine, California, United States, 92612

Sponsors and Collaborators

University of California, Irvine

Beckman Laser Institute Medical Clinic

Otolaryngology Medical Clinic,University of California, Irvine

Genneral Clinical Research Center, University of California, Irvine

Investigators


Principal Investigator:	Petra Wilder-Smith, DDS,PhD	Beckman Laser Institute, University of Calfornia Irvine

More Information

Responsible Party:	Beckman Laser Institute ( Petra Wilder-Smith, DDS,PhD )
Study ID Numbers:	RR-01192, EB-00293, P41-RR01192;NIH-LAMMP
First Received:	October 4, 2007
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00540774
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

oral cancer

oral mucositis

oral stomatitis

Study placed in the following topic categories:

Stomatitis

Mucositis

Oral cancer

Lip and oral cavity cancer

ClinicalTrials.gov processed this record on May 15, 2008

Sponsors and Collaborators:	University of California, Irvine Beckman Laser Institute Medical Clinic Otolaryngology Medical Clinic,University of California, Irvine Genneral Clinical Research Center, University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00540774