Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions - Full Text View

Purpose

Primary Objectives:

To develop noninvasive methods to diagnose neoplasia and dysplasia in oral cavity mucosa using fluorescence and reflectance spectroscopy.
Pathologic specimens and clinical diagnosis of the test mucosa will be correlated with the spectral analysis obtained before biopsy.
Previous pilot investigations have achieved cursory algorithms of diagnosis, and these will be refined in a similar but larger patient population.

Condition	Intervention
Oral Cancer	Procedure: Fluorescence Spectroscopy

MedlinePlus related topics:

Cancer Oral Cancer

U.S. FDA Resources

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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

The goal of this clinical research study is to test a new way to look for cancer and pre-cancerous tissue changes inside the mouth. [ Time Frame: 11 Years ] [ Designated as safety issue: No ]

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	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Any person 18 years of age or older with a lesion of the oral mucosa.
Persons with changes in existing lesions or those who develop new lesions can be re-evaluated, but it is not required.

Exclusion Criteria: None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507182

Contacts


Contact: Ann M. Gillenwater, MD	713-792-8841

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Ann M. Gillenwater, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators


Principal Investigator:	Ann M. Gillenwater, MD	U.T.M.D. Anderson Cancer Center

More Information

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