Polarized Reflectance Spectroscopy for Oral Lesions

NCT01604759 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-01-31

No results posted yet for this study

Summary

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.

Conditions

  • Oral Cancer

Interventions

DEVICE

Polarized Reflectance Spectroscopy System

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

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER
  • University of Texas at Austin

    collaborator OTHER
  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Catherine Poh, M.D. Ph.D · British Columbia Cancer Agency

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01604759 on ClinicalTrials.gov