Neoplasms

Mouth and Tooth Diseases

All Conditions

Rare Diseases

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Patients with lesions of the oral cavity mucosa.

Interview taking about 10 minutes to complete.

Interview

Ann M. Gillenwater, MD

To obtain data to evaluate whether multispectral digital imaging can assist clinicians to screen for premalignant lesions in the oral cavity. Our system will illuminate tissue with monochromatic light to excite fluorescence, and polarized white light to generate reflectance, exposing abnormalities for real time, clinical diagnosis.

Primary Objectives:

1. To compare fluorescence images of oral mucosa lesions, obtained at 350 nm, 380 nm, 400 nm, and 450 nm excitation, to standard white light images and pathologic analysis of biopsied tissue.
2. To compare reflectance images of oral mucosa lesion, obtained using broadband polarized light, to standard white light images and pathologic analysis of biopsied tissue.
3. To develop algorithms to discriminate between normal and abnormal tissue
4. To analyze images to determine which type of optical information (or combination thereof) yields the most diagnostically useful data

All tissue and cells are made of tiny particles that give off small amounts of light. This light is called fluorescence. Scientists have learned that cancerous cells and normal cells give off different amounts and different types of fluorescence. Scientists need to better understand whether fluorescence from the oral cavity (mouth) can be used to tell which cells are abnormal. This information can help doctors detect pre-cancers.

In order to better understand fluorescence, researchers at the Optical Spectroscopy and Imaging Lab, Department of Bioengineering, Rice University have developed an instrument that can collect and analyze fluorescence without surgically removing any tissue or touching the tissue. This instrument takes pictures of oral cavity fluorescence through a microscope. The instrument also takes regular live pictures. Scientists hope to study the pictures to better understand the differences in fluorescence from normal and abnormal cells. The instrument is a standard medical microscope similar to ones used by doctors in their offices to examine people's ears. Researchers have attached a special light source to the microscope that provides different colors of light. In addition, the microscope has a digital camera attached to it so that the researchers can record what they see with the different light colors.

In this study, a clinician will use the instrument to take pictures of suspicious and normal oral cavity lesions. A small sample of the oral lesion (2-4 mm each, the size of a small eraser) will be removed or biopsied from the areas that are imaged. A portion of both the suspicious and normal areas will be taken to pathology for evaluation. The biopsy from the normal appearing area is a biopsy that is additional to those you will receive as part of your standard of care. Each participant will have 2-4 biopsies performed, depending upon how many areas the examiner feels may be suspicious. Most people who take part in this study will be having surgery to remove lesions in the oral cavity anyway, so the biopsies will be performed at the time of surgery. For those participants who are not scheduled to have surgery, the biopsies will be performed under local anesthesia in the clinic.

All data will be numerically coded to ensure your confidentiality.

In addition to the pictures taken and the biopsy, a brief interview will be performed by the clinical research staff to discuss possible past local therapies and your personal history of tobacco and alcohol use. The interview should take about 10 minutes to complete.

You will not be told of any of the experimental findings. Information confirming the diagnosis will be made available to your treating physician. After this visit and tissue collection, your participation in this study will be complete.

This is an investigational study. A total of 45 patients will take part in this study. All will be enrolled at M. D. Anderson.

Pictures of suspicious and normal oral cavity lesions along with small sample of oral lesion (2-4 mm each, the size of a small eraser) will be removed or biopsied from the areas imaged.

Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions

National Institutes of Health (NIH)

National Institute of Dental and Craniofacial Research (NIDCR)

M.D. Anderson Cancer Center

Multispectral digital microscope (MDM) + FastEEM4 Systems

The FastEEM4 probe is moved toward the edge of the lesion(s) until it measures what appears to be normal mouth tissue.

FastEEM4 System

The MDM instrument will take pictures of abnormal-appearing and normal-appearing areas in the mouth.

Multispectral Digital Microscope

The goal of this clinical research study is to evaluate an imaging technology that may help clinicians see how far an area of pre-cancerous or cancerous tissue extends in the mouth.

Fluorescence and Reflectance:

All tissue and cells are made up of tiny particles that give off small amounts of light. This light is called fluorescence. Cancerous cells and normal cells give off different amounts and types of fluorescence and also reflect (bounce back) light differently. Researchers want to better understand if fluorescence and reflectance from mouth tissue can be used to tell which cells are abnormal. This information may help doctors detect early mouth cancers and treat all areas affected by cancerous changes.

The MDM Instrument, FastEEM4 Instrument, POS Instrument, PS2 Instrument, and the IMS Instrument:

Five (5) instruments have been developed:

* the multispectral digital microscope (MDM), a microscope that allows fluorescence and reflectance to be collected;
* the FastEEM4, which can shine different colors of light on the mucosa (the lining of the mouth), which allows fluorescence and reflectance to be collected and looked at without surgically removing any tissue;
* the portable optical spectroscopy (POS) instrument, which is a smaller, portable version of the FastEEM4 device;
* the portable screening system (PS2), which can take images and measurements both in reflectance and in fluorescence mode; and
* the image mapping spectrometer (IMS), which is PS2 and POS combined.

The MDM system is a modified standard medical microscope similar to what doctors use to examine people's ears. A special light source has been attached to this microscope to provide different colors of light that can shine in the mouth. This microscope also has a digital camera attached to it so that researchers can take pictures of fluorescence and reflectance in the mouth in order to record what is seen with the different light colors. Researchers want to study the pictures in order to better understand the differences in fluorescence and reflectance from normal and abnormal cells.

The PS2 is an imaging device for examining the mouth without touching the mouth. The PS2 uses a blue light source in fluorescence mode. The light passes through a filter and shines on the tissue area. A filter is placed in the path to collect only the fluorescent light given off from the tissue. In reflectance mode, a white light is used. Images are collected using a device and a laptop with a software interface. A set of fluorescence and reflectance images can be taken in less than a minute.

The IMS is also an imaging device for examining the mouth without touching the mouth. The IMS includes white and blue light, a camera lens, customized optics (mirror, prisms, and lenses), a filter, a camera, and a computer. In reflectance mode, a white light shines on the tissue area, and specialized optics put the data on the camera. In fluorescence mode, the blue light highlights the tissue. A filter blocks the blue light, which allows tissue fluorescence to be seen. The IMS uses the same light sources as the PS2.

The FastEEM4 system (nonstandard imaging technology) has a probe (a small device used for measuring and/or detecting) that is about the size of a pencil. The probe is placed gently against the mucosa, and different colors of light are directed through the probe to a small area (the lesion and the normal-appearing area) of mouth tissue. Then the fluorescence and reflectance is recorded by a computer.

The POS instrument will direct different colors of light 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 fluorescence. This light cannot be seen by the eye, but is seen by a computer.

Use of the MDM, PS2, or IMS Instruments:

If you agree to take part in this study, a clinician may first use the MDM, PS2, or IMSsystem. If one of these systems are used, the clinician will examine the inside of your mouth with a gloved finger while using standard white light or one or more of the imaging systems for viewing. The instrument will then take pictures of abnormal-appearing and normal-appearing areas in the mouth. The edge between these areas will then be marked with a surgical pen to outline the border between the abnormal-appearing tissue and normal-appearing tissue to be seen on a digital photo. Imaging with each device will take about 2 minutes or less. Between each use of the instrument, it will be sterilized according to standard practices.

Use of the FastEEM4 and/or POS Instruments:

The clinician may then use the FastEEM4 and/or the POS systems. If the FastEEM4 and/or POS systems are used, you will have a FastEEM4 and/or POS probe(s) placed gently on the mouth lesion(s). Several measurements will then be taken by moving the probe(s) a short distance at a time, toward the edge of the lesion(s), until it measures what appears to be normal mouth tissue.

Biopsies and Tissue Removal:

You may be having surgery to remove abnormal-appearing mouth lesions as part of standard care, so the study biopsies and tissue removal may be done at the same time as your surgery. After the surgeon has finished surgery and removed tissue from your mouth as part of your standard treatment, a portion of tissue (from both the abnormal-appearing and normal-appearing areas) that was already removed by the surgeon may be separated out from the main tissue specimen and separately evaluated. This is done so that the researchers can better compare the appearance and diagnosis at these sites to the images that were taken. In addition, a biopsy may be taken from the area of normal-appearing tissue from the opposite side of the mouth that was imaged with the FastEEM4 and/or POS probe(s), if the FastEEM4 and/or POS system(s) were used. If it is performed, this one biopsy of normal appearing tissue will be in addition to what is removed for standard care.

If this biopsy is performed, a small sample (4 mm, about the size of a small pencil eraser) of the lining of your mouth will be removed, while you are asleep under general anesthesia, from the area of normal-appearing tissue from the opposite side of the mouth that was imaged by both instruments.

Length of Study:

You will not be told of any experimental findings of this study. Information about the diagnosis will be available to your treating doctor. After tissue collection is complete, your participation in this study will be over.

All data (such as the tissue images and pathologic diagnosis) will be coded with a number instead of your personal identifying information (such as your name or medical record number) to help ensure your privacy.

This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Tissue removal and study biopsies to be done so that researchers can better compare the appearance and diagnosis at these sites to the images that were taken.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions	NCT00502580	Oral Cancer	Interview	18 Years -	M.D. Anderson Cancer Center
Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions	NCT00502580	Oral Cancer	Interview	18 Years -	M.D. Anderson Cancer Center
Oral Margin Spectroscopy Detection Using Optical Spectroscopy	NCT00439205	Oral Tumors	FastEEM4 System Multispectral D...	18 Years -	M.D. Anderson Cancer Center
Evaluation of a Multispectral Vision Enhancement System for Assessment of Oral Mucosal Lesions	NCT00502580	Oral Cancer	Interview	18 Years -	M.D. Anderson Cancer Center

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