Optical Sensor for Photodynamic Detection of Oral Pathology

Mouth Diseases Clinical Trial

Official title:

Optical Sensor for Photodynamic Detection of Oral Pathology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00540774
• Other study ID #: 20022805
• Secondary ID: R44CA265514T31IR
• Status: Recruiting
• Phase: N/A
• Start date: April 2003
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: University of California, Irvine
• Contact: Nicole Wakida, PhD
• Phone: 949-824-4360
• Email: nwakida[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

1. Coherence and Doppler Tomography

2. Laser Speckle Imaging

3. Various forms of Spectroscopy

4. Fluorescence

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:

1. Coherence and Doppler Tomography (OCT)

2. Laser Speckle Imaging (LSI)

3. Photon Migration Spectroscopy (PMS)

4. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Mouth Diseases

Intervention

Device:
• detection of oral pathology
detection of oral pathology

Locations

Country	Name	City	State
United States	Beckman Laser Institute and Medical Clinic	Irvine	California

Sponsors (7)

Lead Sponsor	Collaborator
University of California, Irvine	Livionex Inc., National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH), Orahealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 12 months