Optical Sensor for Photodynamic Detection of Oral Pathology
Primary Purpose
Mouth Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
detection of oral pathology
Sponsored by
About this trial
This is an interventional diagnostic trial for Mouth Diseases focused on measuring Oral cancer, Oral mucositis, Periodontitis, Dry mouth, Gingivitis, Oral lesions, Dental Hard Tissues, Oral Biofilm
Eligibility Criteria
Inclusion Criteria:
- Male or Female age 18 years and older
- Have oral lesion or not have oral lesion
- Have condition of dry mouth
- Have condition of Gum disease
- Non-smoker
Exclusion Criteria:
- Age less than 18 years old
- Advanced gum disease, diseases of oral tissue
- Untreated cavities
- Pregnant or breastfeeding
- Immune compromised individuals
Sites / Locations
- Beckman Laser Institute, University of California IrvineRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Oral tissue
Arm Description
Imaging of oral structures and pathologies
Outcomes
Primary Outcome Measures
Healthy oral tissue
Develop a non-invasive tool for the detection, diagnosis and screening of oral pathology and understanding of processes involved in oral pathology
Secondary Outcome Measures
Full Information
NCT ID
NCT00540774
First Posted
October 4, 2007
Last Updated
October 31, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine, National Institutes of Health (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR), Livionex Inc, Orahealth
1. Study Identification
Unique Protocol Identification Number
NCT00540774
Brief Title
Optical Sensor for Photodynamic Detection of Oral Pathology
Official Title
Optical Sensor for Photodynamic Detection of Oral Pathology
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2003 (undefined)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
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, National Institutes of Health (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Cancer Institute (NCI), National Institute of Dental and Craniofacial Research (NIDCR), Livionex Inc, Orahealth
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Overall objective of this work is to develop better ways of detecting, diagnosing and measuring oral diseases and structures using light and optical approaches. All different areas of the mouth will be imaged, including healthy, diseased, dysplastic and malignant, as well as oral biofilm, and the imaging data compared against conventional diagnostic approaches such clinical and histopathological and molecular evaluations to (1) gain a better understanding of processes involved in oral pathology and (2) develop a combined patient specific, non-invasive method for the detection, diagnosis and screening of oral pathology and biofilm. Thus our goal is to identify and evaluate microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia.
We are recruiting patients with a wide range of oral conditions including plaque, dry mouth, toothache, root canal treatments, gum disease, oral sores, dysplasia and cancer, autoimmune conditions and others as well as healthy control subjects. We will use a range of non-invasive imaging modalities to obtain information on the ways in which the oral health status affects optical properties, and determine means of detecting and quantifying these factors.. Imaging modalities to be utilized include:
Coherence and Doppler Tomography
Laser Speckle Imaging
Various forms of Spectroscopy
Fluorescence
Detailed Description
Purpose of the research is to identify optical predictors and biomarkers of health and disease.
Hypothesis: microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia.
Researchers of the Beckman Laser Institute (BLI) have developed many non-invasive imaging modalities for assessment of oral tissue. This protocol will allow data acquisition with these multiple modalities to allow validation of data. Imaging modalities to be utilized include:
Coherence and Doppler Tomography (OCT)
Laser Speckle Imaging (LSI)
Photon Migration Spectroscopy (PMS)
Autofluorescence Imaging
In addition, saliva samples from the patients will be analyzed and the resulting data regarding the dysregulation in the activities of genes, proteins and other molecules will be correlated with findings from different imaging systems with respect to the stage of oral carcinogenesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mouth Diseases
Keywords
Oral cancer, Oral mucositis, Periodontitis, Dry mouth, Gingivitis, Oral lesions, Dental Hard Tissues, Oral Biofilm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
2500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral tissue
Arm Type
Other
Arm Description
Imaging of oral structures and pathologies
Intervention Type
Device
Intervention Name(s)
detection of oral pathology
Intervention Description
detection of oral pathology
Primary Outcome Measure Information:
Title
Healthy oral tissue
Description
Develop a non-invasive tool for the detection, diagnosis and screening of oral pathology and understanding of processes involved in oral pathology
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or Female age 18 years and older
Have oral lesion or not have oral lesion
Have condition of dry mouth
Have condition of Gum disease
Non-smoker
Exclusion Criteria:
Age less than 18 years old
Advanced gum disease, diseases of oral tissue
Untreated cavities
Pregnant or breastfeeding
Immune compromised individuals
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna Kim, MA
Phone
949-824-9265
Email
hhkim3@uci.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Wilder-Smith, DDS,PhD
Organizational Affiliation
Beckman Laser Institute, University of Calfornia Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute, University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Kim, MA
Phone
949-824-9265
Email
hhkim3@uci.edu
First Name & Middle Initial & Last Name & Degree
Petra Wilder-Smith, DDS,PhD
12. IPD Sharing Statement
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Optical Sensor for Photodynamic Detection of Oral Pathology
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