Fluorescence & Reflectance Imaging to Detect Oral Neoplasia
The goal of this clinical research study is to evaluate fluorescence imaging (including a new handheld device), widefield fluorescence imaging, and/or point spectroscopy imaging methods 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 overall objective of this exploratory study is to evaluate whether widefield multispectral imaging and/or point spectroscopy can assist in follow-up surveillance of patients with high risk for development of oral cancer including those with premalignant lesions in the oral cavity. Digital images obtained using various light wavelength combinations and spectroscopy of specific lesions will be used to examine patients at high risk for oral cancer during routine clinical follow-up examinations. Data will be correlated with standard clinical examination, development of dysplasia and invasive carcinoma, and pathological evaluation of biopsies when available.
The specific aims of the study are:
- To compare images of oral mucosa, obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation, to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression.
- To assess whether the multispectral images and spectroscopic data provide any added benefit to assist clinicians in surveillance of high risk patients.
This will be an exploratory study designed to obtain images and/or spectroscopic data over time during routine follow-up surveillance of patients at high risk to develop oral cancer. We will investigate based on the following hypotheses:
- The optical properties of epithelial tissue are altered due to biochemical and architectural changes occurring during malignant conversion. These alterations can be optically detected and used for diagnosis.
- The human eye can better distinguish alterations in optical properties between non-neoplastic, dysplastic and malignant oral mucosa with the assistance of fluorescence and reflectance imaging.
Procedure: Portable Spectroscopy System
Procedure: Multispectral Digital Microscope
Procedure: Fast Excitation-Emission Matrix System
|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|
- 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 ]
|Study Start Date:||August 2007|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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: PS2Procedure: 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: MDMProcedure: 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
Hide 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.
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.
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.
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 M. D. Anderson for clinic visits.
This is an investigational study. Up to 200 patients will take part in this study. All will be enrolled at MD Anderson.
|Contact: Ann M. Gillenwater, MD||713-792-6920|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Ann M. Gillenwater, MD|
|Principal Investigator:||Ann M. Gillenwater, MD||M.D. Anderson Cancer Center|