Fluorescence & Reflectance Imaging to Detect Oral Neoplasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00542373
First received: October 10, 2007
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

The goal of this clinical research study is to evaluate fluorescence imaging, widefield fluorescence imaging, point spectroscopy imaging methods, and or/ oral brush cytology that may help doctors monitor patients at an increased risk of developing an oral cancer, including those with pre-cancerous lesions in the mouth.


Condition Intervention
Oral Cancer
Procedure: Portable Spectroscopy System
Procedure: Multispectral Digital Microscope
Procedure: Fast Excitation-Emission Matrix System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Fluorescence & Reflectance Imaging to Detect Oral Neoplasia

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Evaluate Portable Spectroscopy System (PS2), Multispectral Digital Microscope (MDM), + Fast Excitation-Emission Matrix (EEM) Imaging Methods [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: August 2007
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PS2 + MDM + Fast EEM4
PS2 imaging system that shines different wavelengths (colors) of light in the mouth and can collect and analyze fluorescence and reflected light. MDM imaging system that takes fluorescence and reflectance pictures through a dental microscope. Different colors of light are used to shine in the mouth and pictures are taken using a digital camera. Fast EEM4 - Different colors of light are directed through fibers to the lining of the mouth and then light is collected and sent to a special camera and a computer to be analyzed.
Procedure: Portable Spectroscopy System
Imaging system that shines different wavelengths (colors) of light in the mouth and can collect and analyze fluorescence and reflected light.
Other Name: PS2
Procedure: Multispectral Digital Microscope
Imaging system that takes fluorescence and reflectance pictures through a dental microscope. Different colors of light are used to shine in the mouth and pictures are taken using a digital camera.
Other Name: MDM
Procedure: Fast Excitation-Emission Matrix System
Different colors of light are directed through fibers to the lining of the mouth and then light is collected and sent to a special camera and a computer to be analyzed.
Other Name: Fast EEM4

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Subjects with premalignant lesion, or potentially premalignant lesion, of the oral cavity mucosa (leukoplakia or erythroplakia).
  2. Patients with a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease.
  3. Persons with any other condition (such as lichen planus, Fanconi anemia, heavy tobacco use, etc) making them at higher risk for oral cancer development.
  4. Patients with either pre-malignant or a history of oral cancer based on patient history and clinical presentations

Exclusion Criteria:

  1. Subjects under the age of 18.
  2. Subjects that are unable or unwilling to give informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542373

Contacts
Contact: Ann M. Gillenwater, MD 713-792-6920

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Ann M. Gillenwater, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ann M. Gillenwater, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00542373     History of Changes
Other Study ID Numbers: 2006-0802
Study First Received: October 10, 2007
Last Updated: September 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Oral Cancer
Oral Cavity Mucosa
Leukoplakia
Erythroplakia
Fluorescence Imaging
Reflectance Imaging
Multispectral Digital Microscope
Portable Spectroscopy System
Fast Excitation-Emission Matrix
PS2
MDM
Fast EEM4

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

ClinicalTrials.gov processed this record on October 01, 2014