Clinical trial NCT00540774: Optical Sensor for Photodynamic Detection of Oral Pathology
Official title: Optical Sensor for Photodynamic Detection of Oral Pathology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mouth Diseases
Keywords: Oral cancer
Oral mucositis
Periodontitis
Dry mouth
Gingivitis
Oral lesions
Dental Hard Tissues
Oral Biofilm
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
name: National Institute of Dental and Craniofacial Research (NIDCR)
name: Livionex Inc.
name: Orahealth
name: National Cancer Institute (NCI)
First posted: 2007-10-08
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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:

1. Coherence and Doppler Tomography
2. Laser Speckle Imaging
3. Various forms of Spectroscopy
4. 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:

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.

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

Primary outcomes:
measure: Healthy oral tissue
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute and Medical Clinic
state: California
Study officials:
affiliation: University of Calfornia Irvine
name: Petra Wilder-Smith, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: