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Fluorescence & Reflectance Imaging to Detect Oral Neoplasia

This study is currently recruiting participants.
Verified August 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00542373
First Posted: October 11, 2007
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    Information obtained from the multispectral images compared with the clinical diagnosis, long-term outcome and the histopathology of any biopsied tissue to evaluate the performance of the optical system and assess any clinical benefit to assist in surveillance.


Estimated Enrollment: 300
Actual Study Start Date: August 2007
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ann M. Gillenwater, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00542373     History of Changes
Other Study ID Numbers: 2006-0802
NCI-2015-01903 ( Registry Identifier: NCI CTRP )
5R01CA185207 ( U.S. NIH Grant/Contract )
First Submitted: October 10, 2007
First Posted: October 11, 2007
Last Update Posted: August 22, 2017
Last Verified: August 2017

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