Polarized Reflectance Spectroscopy for Oral Lesions

NCT01604759 | Completed Phase 1

• 2 other identifiers: H10-013135RO1EB00354004 (PC-1)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.Polarized reflectance spectroscopy can distinguish high-risk oral lesion from normal and reactive oral lesions.
2. 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

Keywords

Mouth Neoplasms; Mouth Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Polarized probe measurement.

OTHER

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.

Device: Polarized Reflectance Spectroscopy System

Interventions

Polarized Reflectance Spectroscopy System DEVICE

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

Also known as: Polarized Reflectance Spectroscopy System., Research device developed at MD Anderson Cancer Centre, Dept of Imaging Physics specifically for this study.

Polarized probe measurement.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• You are under the age of 18 years.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• M.D. Anderson Cancer Center: collaborator
• University of Texas at Austin: collaborator

Study Sites (1)

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 1L3, Canada

Location

MeSH Terms

Conditions

Mouth Neoplasms; Mouth Diseases

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Stomatognathic Diseases

Study Officials

• Catherine Poh, M.D. Ph.D

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: May 24, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

CA (1)