Polarized Reflectance Spectroscopy for Oral Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-12-31

Brief Summary

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In this study the investigators are conducting research to determine whether a new optical device using polarization reflectance spectroscopy can help doctors or dentists identify abnormalities in the mouth that require follow-up. To establish this, measurements are needed from a large number of individuals with different abnormalities in their mouth.

The investigators believe the proposed approach has potential to improve and enable mass screening for precancerous and early cancers of the oral cavity by improving the predictive value of oral cavity exams, particularly for less experienced practitioners.

The information from this study will be compared to results from the pathology report of the tissue taken from your mouth.

Hypothesis:

1. Polarized reflectance spectroscopy can distinguish high-risk oral lesion from normal and reactive oral lesions.
2. Polarized reflectance spectroscopy can capture low-grade oral lesions that have characteristics associated with a high risk of progression to cancer.

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Detailed Description

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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.

Conditions

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Oral Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Polarized probe measurement.

All patients belong under this arm as all will be measured by the polarized probe and the data will be compared to the biopsy site's pathology results.

Group Type OTHER

Polarized Reflectance Spectroscopy System

Intervention Type DEVICE

Fiber optic probe designed to measure polarized reflectance spectroscopy will be used to gather data from all study participants.

Interventions

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Polarized Reflectance Spectroscopy System

Fiber optic probe designed to measure polarized reflectance spectroscopy will be used to gather data from all study participants.

Intervention Type DEVICE

Other Intervention Names

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Polarized Reflectance Spectroscopy System. Research device developed at MD Anderson Cancer Centre, Dept of Imaging Physics specifically for this study.

Eligibility Criteria

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Inclusion Criteria

* You attend the Dental Department at the British Columbia 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