Polarized Reflectance Spectroscopy for Oral Lesions (PolProbe)

This study is currently recruiting participants.
Verified June 2013 by British Columbia Cancer Agency
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
University of Texas at Austin
Information provided by (Responsible Party):
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01604759
First received: November 3, 2010
Last updated: June 20, 2013
Last verified: June 2013

November 3, 2010
June 20, 2013
December 2011
September 2013   (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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
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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.

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Sylvia Lam 604-675-8093 sflam@bccrc.ca
Canada
 
NCT01604759
H10-01313, 5RO1EB00354004 (PC-1)
No
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
June 2013

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