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Polarized Reflectance Spectroscopy for Oral Lesions (PolProbe)

This study is currently recruiting participants.
Verified May 2012 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: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Oral Cancer
 Device: Polarized Reflectance Spectroscopy System
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Polarized Reflectance Spectroscopy for Detection of High-risk Oral Lesions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 150
Study Start Date: December 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604759

Contacts
Contact: Sylvia Lam 604-675-8093 sflam@bccrc.ca

Locations
Canada, British Columbia
BC Cancer Agency - Vancouver Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1L3
Contact: Sylvia Lam     604-675-8093     sflam@bccrc.ca    
Principal Investigator: Catherine Poh, M.D. Ph.D            
Sponsors and Collaborators
British Columbia Cancer Agency
M.D. Anderson Cancer Center
University of Texas at Austin
Investigators
Principal Investigator: Catherine Poh, M.D. Ph.D British Columbia Cancer Agency
  More Information

No publications provided

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01604759     History of Changes
Other Study ID Numbers: H10-01313, 5RO1EB00354004 (PC-1)
Study First Received: November 3, 2010
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by British Columbia Cancer Agency:
Mouth Neoplasms
Mouth Diseases

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Neoplasms
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 16, 2013