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Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507182
First Posted: July 26, 2007
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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.

Condition Intervention
Oral Cancer Procedure: Fluorescence Spectroscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fluorescence and Reflectance Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Classification of Oral Lesions [ Time Frame: 11 Years ]
    Distinguishing between normal and abnormal sites with four lesion classifications of normal, non-malignant inflammatory, dysplasia, and neoplasia.


Enrollment: 259
Actual Study Start Date: July 1999
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluorescence Spectroscopy
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.
Procedure: Fluorescence Spectroscopy
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507182


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ann M. Gillenwater, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00507182     History of Changes
Other Study ID Numbers: HNS99-100
NCI-2012-01601 ( Registry Identifier: NCI CTRP )
First Submitted: July 24, 2007
First Posted: July 26, 2007
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by M.D. Anderson Cancer Center:
Oral Mucosa Lesions
Oral Cancer
Neoplasia and Dysplasia in oral cavity mucosa
Fluorescence Spectroscopy
Reflectance Spectroscopy
Pre-cancerous lesions
Cancerous lesions
Mouth

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases