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OpenTrials
Completed

NCT Number: NCT01604759

Polarized Reflectance Spectroscopy for Oral Lesions

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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Key information

Conditions

Oral Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 1L3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • You are under the age of 18 years.

Treatment and study plan

Polarized Reflectance Spectroscopy System

Device

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

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

Primary outcomes

  1. To use the spectroscopic data collected to create a model for normal, dysplastic and cancerous tissue.

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Collaborators

  • M.D. Anderson Cancer Center
  • University of Texas at Austin

Registry information

Official study title

Evaluation of Polarized Reflectance Spectroscopy for Detection of High-risk Oral Lesions

Acronym: PolProbe

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 24, 2012
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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