Optical Sensor for Photodynamic Detection of Oral Pathology

University of California Irvine (UCI)

Status: Suspended

Conditions: Mouth Diseases

Treatments: Device: detection of oral pathology

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00540774

R01DE022831 (U.S. NIH Grant/Contract)

20022805

R44CA265514 (U.S. NIH Grant/Contract)

UCI-08-52 (Other Identifier)

R03EB014852 (U.S. NIH Grant/Contract)

T31IR1825 (Other Grant/Funding Number)

LDG (Other Identifier)

OE (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,500 participants in 1 patient group

Oral tissue

Other group

Description:

Imaging of oral structures and pathologies

Treatment:

Device: detection of oral pathology