Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions

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Brief Title

Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions

Official Title

Fluorescence and Reflectance Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions

Brief Summary

      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.
    

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 may have 1 to 5 lesions and several normal-looking areas inside the mouth
      exposed to a beam of light. The exposed tissues may 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 may 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 may also be removed during
      surgery. Patients who do not need surgery may 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.

      If you are scheduled to participate in another MD Anderson study, Protocol 2008-0137
      Entitled, "Phase Ib Study of Erlotinib Prior to Surgery in Patients with Head and Neck
      Cancer" (Study Chair: Dr. William William), some of your collected tissue samples may be
      shared with Dr. William for use on 2008-0137.

      This is an investigational study. About 395 patients will be consented and screened for this
      study, with about 381 to take full part in this study. All will be treated at MD Anderson.
    


Study Type

Interventional


Primary Outcome

Classification of Oral Lesions


Condition

Oral Cancer

Intervention

Fluorescence Spectroscopy

Study Arms / Comparison Groups

 Fluorescence Spectroscopy
Description:  1-5 lesions + several normal-looking areas inside the mouth exposed to a beam of light; exposed tissues will emit very small amounts of fluorescence (light) then will be removed.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

381

Start Date

July 2, 1999

Completion Date

January 12, 2018

Primary Completion Date

January 12, 2018

Eligibility Criteria

        Inclusion Criteria:

        1. 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:

        NA
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ann M. Gillenwater, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00507182

Organization ID

HNS99-100

Secondary IDs

NCI-2012-01601

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center


Study Sponsor

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


Verification Date

January 2018