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Sponsored by: |
M.D. Anderson Cancer Center |
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00507182 |
Primary Objectives:
Condition | Intervention |
Oral Cancer |
Procedure: Fluorescence Spectroscopy |
MedlinePlus related topics: | Cancer Oral Cancer |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Fluorescence and Reflectance Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions |
Estimated Enrollment: | 205 |
Study Start Date: | July 1999 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Fluorescence Spectroscopy
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Procedure: Fluorescence Spectroscopy
1 to 5 lesions and several normal-looking areas inside the mouth will be exposed to a beam of light. The exposed tissues will emit very small amounts of light called fluorescence. The small areas exposed to the light beam will then be removed.
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Abnormal-looking areas (lesions) inside the mouth may be a sign of cancer or changes that may lead to cancer. These lesions may need to be removed. Researchers are looking for a practical way to tell early on whether these lesions are cancer or may become cancer. This study will test a technique called fluorescence spectroscopy, which is under research in this study.
Each patient will have 1 to 5 lesions and several normal-looking areas inside the mouth exposed to a beam of light. The exposed tissues will emit very small amounts of light called fluorescence. This light is not seen by the eye but is detected by a computer. The small areas exposed to the light beam will then be removed.
The patients who need surgery may have the small tested areas removed when the lesions are surgically removed. A small sample from a normal-looking area will also be removed during surgery. Patients who do not need surgery will simply have small samples taken from the lesions and a normal-looking area in the clinic rather than in the operating room. The tissues will be looked at under a microscope to see whether they are cancerous. These results will be compared with the spectroscopy results.
This is an investigational study. About 300 patients will be consented and screened for this study, with about 205 to take full part in this study. All will be treated at M. D. Anderson.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria: None
Contact: Ann M. Gillenwater, MD | 713-792-8841 |
United States, Texas | |||||
U.T.M.D. Anderson Cancer Center | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Principal Investigator: Ann M. Gillenwater, MD |
M.D. Anderson Cancer Center |
Principal Investigator: | Ann M. Gillenwater, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Ann M. Gillenwater, MD/Associate Professor ) |
Study ID Numbers: | HNS99-100 |
First Received: | July 24, 2007 |
Last Updated: | February 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00507182 |
Health Authority: | United States: Institutional Review Board |
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