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Trial record 10 of 2060 for:    Oral Cancer | NIH

Fluorescence & Reflectance Imaging to Detect Oral Neoplasia

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ClinicalTrials.gov Identifier: NCT00542373
Recruitment Status : Recruiting
First Posted : October 11, 2007
Last Update Posted : August 22, 2017
Sponsor:
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Oral Cancer Procedure: Portable Spectroscopy System Procedure: Multispectral Digital Microscope Procedure: Fast Excitation-Emission Matrix System Not Applicable

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Detailed Description:

The Imaging Methods:

All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. This light is called fluorescence. Researchers have learned that cancerous cells and normal cells give off different amounts and different types of fluorescence and also reflect light differently. Researchers need to better understand whether fluorescence and reflectance of light from tissues in the mouth can be used to tell whether areas of the mouth are abnormal. This information may help doctors detect pre-cancers and early cancer.

Fluorescence Imaging:

Researchers have developed instruments that shine different wavelengths (colors) of light in the mouth and can collect and analyze fluorescence and reflected light. This is an imaging system that takes fluorescence pictures through a portable head light.

A second, handheld device, named the Identafi 3000, is similar in size and shape to a standard dental mirror. It uses white, violet, and amber light to highlight abnormal tissue areas. The users, wearing special filter eyeglasses, can evaluate and identify changes in the mouth.

Widefield Fluorescence Imaging:

This is an 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. Researchers hope to study the pictures to better understand the differences in fluorescence from normal and abnormal cells.

Point Spectroscopy System:

This study may also test a technique called fluorescence and reflectance spectroscopy.

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. The spectroscopy system has a small probe about the size of a writing pen which is placed gently against the lining of the mouth. The exposed tissues will give off very small amounts of light called fluorescence. This light is not seen by the eye, but is seen by a computer.

Brush Cytology:

This is a method to analyze cells from the lining of the mouth. A brush is used to scrape cells from the mouth. The cells can then be stained and checked under a microscope for pre-cancerous changes.

Study Procedures:

If you agree to take part in this study, a researcher may use fluorescence and/or widefield fluorescence imaging instruments to take pictures of several areas in the mouth. Then, the researcher may gently place point spectroscopy probe on 1-4 normal-looking areas and 1-4 abnormal areas. Different colors of light will be shone on the lining of the mouth through the probe. The light that returns from the tissue is collected through the probe and recorded on the computer.

Then the researcher may press a brush inside your mouth and rotate 5-10 times to collect cells.

Researchers will record whether the doctor thinks the area is normal, abnormal but not suspicious for cancer, pre-cancer, or cancer.

If your doctor thinks it is necessary, as per standard of care, a biopsy of abnormal areas may be performed. If any biopsies are performed, the information learned from the tissue will be compared with the imaging and spectroscopy data.

These procedures should take about 20 minutes.

Length of Study:

You will be on study until you complete the 1-time imaging.

If you agree to the optional procedures, you will be on study for as long as you continue to return to MD Anderson for clinic visits.

This is an investigational study. Up to 300 patients will take part in this study. All will be enrolled at MD Anderson.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fluorescence & Reflectance Imaging to Detect Oral Neoplasia
Actual Study Start Date : August 2007
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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 Posted: October 11, 2007    Key Record Dates
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