Polarized Reflectance Spectroscopy for Oral Lesions (PolProbe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01604759
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : January 31, 2017
M.D. Anderson Cancer Center
University of Texas at Austin
Information provided by (Responsible Party):
British Columbia Cancer Agency

November 3, 2010
May 24, 2012
January 31, 2017
December 2011
December 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01604759 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Polarized Reflectance Spectroscopy for Oral Lesions
Evaluation of Polarized Reflectance Spectroscopy for Detection of High-risk 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.


  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.

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.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Oral Cancer
Device: Polarized Reflectance Spectroscopy System
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.
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.
Intervention: Device: Polarized Reflectance Spectroscopy System
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2015
December 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
5RO1EB00354004 (PC-1) ( Other Grant/Funding Number: NIH )
Not Provided
Not Provided
British Columbia Cancer Agency
British Columbia Cancer Agency
  • M.D. Anderson Cancer Center
  • University of Texas at Austin
Principal Investigator: Catherine Poh, M.D. Ph.D British Columbia Cancer Agency
British Columbia Cancer Agency
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP