Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12 participants
OBSERVATIONAL
2003-01-31
2009-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with oral lesions
Reflectance Confocal Imaging
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.
Interventions
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Reflectance Confocal Imaging
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.
Eligibility Criteria
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Inclusion Criteria
* Any person with an oral lesion, particularly those suspicious for dysplasia or carcinoma.
Exclusion Criteria
* Oral lesions not physically accessible for probe placement or biopsy
* Unwillingness to tolerate probe placement, dilute acetic acid rinse or biopsy
* Unwillingness to provide informed consent
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ann M. Gillenwater, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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The University of Texas M.D.Anderson Cancer Center
Other Identifiers
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ID02-494
Identifier Type: -
Identifier Source: org_study_id