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| Sponsors and Collaborators: |
University of California, Irvine Beckman Laser Institute University of California Irvine 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 |
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.
| Condition | Intervention |
|---|---|
|
Oral Diseaes Abnormal Oral Mucosa |
Device: OCT/DOS |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | Optical Sensor for Photodynamic Detection of Oral Pathology |
| 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
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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 |
primary care clinic, community sample
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Beckman Laser Institute, University of California Irvine | |
| Irvine, California, United States, 92612 | |
| UCI student health center | |
| Irvine, California, United States, 92612 | |
| 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: | NIH-OCT-EB-093-07, LAMMP MET RR-01192-29, IMALUX |
| Study First Received: | October 4, 2007 |
| Last Updated: | March 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00540774 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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oral cancer oral mucositis oral stomatitis |
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Lip and Oral Cavity Cancer Stomatitis Mucositis Mouth Neoplasms Oral Cancer |
