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| Descriptive Information Fields | |||||
| Brief Title † | Optical Sensor for Photodynamic Detection of Oral Pathology | ||||
| Official Title † | Optical Sensor for Photodynamic Detection of Oral Pathology | ||||
| Brief Summary | 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.
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| 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 |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Case-Only, Prospective | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Oral Diseaes Abnormal Oral Mucosa |
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| Intervention † | Device: OCT/DOS | ||||
| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Enrolling by invitation | ||||
| Enrollment † | 84 | ||||
| Start Date † | April 2003 | ||||
| Completion Date | July 2012 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00540774 | ||||
| Organization ID | RR-01192, EB-00293 | ||||
| Secondary IDs †† | P41-RR01192;NIH-LAMMP | ||||
| Study Sponsor † | University of California, Irvine | ||||
| Collaborators †† | Beckman Laser Institute Medical Clinic Otolaryngology Medical Clinic,University of California, Irvine Genneral Clinical Research Center, University of California, Irvine |
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| Investigators † |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | January 2008 | ||||
| First Received Date † | October 4, 2007 | ||||
| Last Updated Date | January 3, 2008 | ||||
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