ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 210 for:    Oral Cancer | Recruiting Studies | NIH

Fluorescence & Reflectance Imaging to Detect Oral Neoplasia

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.
ClinicalTrials.gov Identifier: NCT00542373
Recruitment Status : Recruiting
First Posted : October 11, 2007
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

October 10, 2007
October 11, 2007
August 23, 2018
August 2007
August 2019   (Final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00542373 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Fluorescence & Reflectance Imaging to Detect Oral Neoplasia
Fluorescence & Reflectance Imaging to Detect Oral Neoplasia
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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Oral Cancer
  • 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
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.
Interventions:
  • Procedure: Portable Spectroscopy System
  • Procedure: Multispectral Digital Microscope
  • Procedure: Fast Excitation-Emission Matrix System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
50
August 2019
August 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Ann M. Gillenwater, MD 713-792-6920
United States
 
 
NCT00542373
2006-0802
NCI-2015-01903 ( Registry Identifier: NCI CTRP )
5R01CA185207 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • National Cancer Institute (NCI)
Principal Investigator: Ann M. Gillenwater, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP