Evaluation of Polarized Reflectance Spectroscopy for Detection of High-risk Oral Lesions
18 Years
N/A
Both
Oral Cancer
Trial Information
Evaluation of Polarized Reflectance Spectroscopy for Detection of High-risk Oral Lesions
The clinician will place a fiber-optic probe designed to measure the polarized reflectance
spectra over the visible optical region on a site of interest in the subject's mouth,
including lesional mucosa, normal adjacent and contralateral mucosa. The site for placement
of the probe will be determined by the examiner, an experienced Oral Pathologist. The probe
examination will take no more than 15 minutes in addition to the subject's appointment time
for their routine visits.
A 4um unstained tissue section from surgery or biopsy, part of their scheduled care, will be
requested for quantitative histological analysis. The morphometric parameters obtained from
polarized reflectance measurements will be compared with the histology and quantitative
pathology (nuclear phenotype score) from the tissue sections from the lesion. The collected
spectra data from normal looking areas from adjacent normal looking mucosa and contralateral
mucosa will be used to determine patient to patient variation in the polarized reflectance
of oral mucosa.
Inclusion Criteria:
- You attend the Dental Department at the BC Cancer Agency
- You have an abnormal lesion in the mouth
- You fully understand the study and give your informed consent to participate as
demonstrated by signing this consent form
Exclusion Criteria:
- You are under the age of 18 years.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To use the spectroscopic data collected to create a model for normal, dysplastic and cancerous tissue.
Outcome Description:
The goals of the statistical analysis will be to determine an appropriate model for predicting whether the lesion is normal or abnormal (dysplasia or carcinoma) based on spectroscopic characteristics. The investigators will estimate sensitivity and specificity of the predictions made by the model and compare this to sensitivity and specificity of standard white light clinical examination currently used in clinical practice.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Catherine Poh, M.D. Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
British Columbia Cancer Agency
Authority:
United States: Institutional Review Board
Study ID:
H10-01313
NCT ID:
NCT01604759
Start Date:
December 2011
Completion Date:
September 2013
Related Keywords:
- Oral Cancer
- Mouth Neoplasms
- Mouth Diseases
- Mouth Neoplasms
Name | Location |
|---|
