Polarized Reflectance Spectroscopy for Oral Lesions

Oral Cancer Clinical Trial

— PolProbe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604759
• Other study ID #: H10-01313
• Secondary ID: 5RO1EB00354004 (
• Status: Completed
• Phase: Phase 1
• First received: November 3, 2010
• Last updated: January 30, 2017
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Cancer

Intervention

Device:
• Polarized Reflectance Spectroscopy System
Fiber optic probe designed to measure polarized reflectance spectroscopy will be used to gather data from all study participants.

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency - Vancouver Centre	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	M.D. Anderson Cancer Center, University of Texas at Austin

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To use the spectroscopic data collected to create a model for normal, dysplastic and cancerous tissue.	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.	2 years