Neoplasms

Mouth and Tooth Diseases

All Conditions

Rare Diseases

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

A photograph will be taken of any abnormal areas inside the mouth. A small probe will expose the oral lining to a small amount of light. Some of this light will be reflected back into the probe, and be picked up by a computer. Pictures will be made of the tissue.

Reflectance Confocal Imaging

Ann M. Gillenwater, MD

The objective of this study is to evaluate the feasibility of using reflectance confocal imaging to noninvasively detect and diagnose oral dysplasia and early carcinoma.

The study will take place at M. D. Anderson. Examinations will be performed in the cancer prevention, head and neck or dental clinics, or the operating room for patients who get scheduled for surgery as part of their standard care.

Abnormal looking areas (lesions) inside the mouth may be a sign of cancer or changes that may lead to cancer. Researchers are looking for a practical way to tell early on whether these lesions are cancer or may become cancer. This study will look at a technique called reflectance confocal imaging.

Participants in this study will have an examination of the mouth. A photograph will be taken of any abnormal areas inside the mouth. Then a small probe, about the size of a large ink pen, will be placed gently against one to two abnormal appearing areas, and one normal appearing area inside the mouth. The probe will expose the oral lining to a small amount of light. Some of this light will be reflected back into the probe, and be picked up by a computer. Pictures will be made of the tissue.

A small amount of vinegar will be placed at each site with a cotton swab before the probe is placed. The procedure takes about 1-2 minutes at each site. A small sample of tissue from each site, both the normal and abnormal, will be removed. The biopsies done on the normal tissue are done for this study only and are not part of standard care. The samples will be removed either at the time of surgery or under local anesthesia in the clinic. Briefly, the small areas to be biopsied will be numbed with topical anesthesia and an injection of local anesthesia. Then a small amount of tissue, about as big as a pencil eraser, will be removed with sterile surgical instruments. This should cause little discomfort or bleeding. The tissue will be placed in a special fluid and then looked at with a special microscope. The tissue samples will be examined with a microscope by a pathologist to learn if the tissue is cancerous or precancerous. These results will be compared with the pictures that were made of the lining of the mouth.

You will not be told of any of the experimental findings. The pathology review of the tissue removed will be available to the treating physician for patient care.

THIS IS AN INVESTIGATIONAL STUDY. The device used for reflectance confocal imaging is an investigational device. It is considered a non-significant risk device by the FDA to be used for research only. A total of 22 patients will take part in this study. All will be enrolled at M. D. Anderson.

In Vivo Confocal Imaging of Oral Mucosa

A Pilot Study: In Vivo Reflectance Confocal Imaging for Detection of Neoplasia of Oral Mucosa

National Institutes of Health (NIH)

M.D. Anderson Cancer Center

Symptoms and General Pathology

Digestive System Diseases

Inflammation

Ulcer

Pain

Mucositis

Oral Ulcer

Michael D Colvard, DDS

These are ethnomedicine studies of plants used by rural and indigenous peoples for pain and oral inflammation relief.

These are ethnomedicine studies of plants used by rural and indigenous peoples for pain relief in Central and South America.

Ethnopharmacological Studies in Oral Medicine

University of Illinois at Chicago

Latin University of Costa Rica

National Center for Complementary and Integrative Health (NCCIH)

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
In Vivo Confocal Imaging of Oral Mucosa	NCT00502125	Oral Tumors	Reflectance Con...	-	M.D. Anderson Cancer Center
In Vivo Confocal Imaging of Oral Mucosa	NCT00502125	Oral Tumors	Reflectance Con...	-	M.D. Anderson Cancer Center
Ethnopharmacological Studies in Oral Medicine	NCT00200837	Oral Pain Oral Ulcers Oral Tumors		-	National Center for Complementary and Integrative Health (NCCIH)
Oral Margin Spectroscopy Detection Using Optical Spectroscopy	NCT00439205	Oral Tumors	FastEEM4 System Multispectral D...	18 Years -	M.D. Anderson Cancer Center
Ethnopharmacological Studies in Oral Medicine	NCT00200837	Oral Pain Oral Ulcers Oral Tumors		-	National Center for Complementary and Integrative Health (NCCIH)

Spots Global Cancer Trial Database for oral tumors

Every month we try and update this database with for oral tumors cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for oral tumors

Every month we try and update this database with for oral tumors cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for oral tumors cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.