Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer

March 3, 2026 updated by: M.D. Anderson Cancer Center

Fluorescence & Reflectance Imaging to Detect Oral Neoplasia

This clinical trial studies widefield fluorescence and reflectance imaging, fluorescence spectroscopy, and tissue samples in regularly examining (monitoring) participants at risk for developing oral cancer. All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. This light is called fluorescence. Fluorescent imaging use instruments that shine different wavelengths (colors) of light in the mouth taking fluorescence pictures through a portable head light or by taking fluorescent and reflectance pictures through a dental microscope using a digital camera. Fluorescent spectroscopy uses a small probe placed gently against the lining of the mouth and the tissue is exposed to small amounts of fluorescent light that is then collected with a special camera and a computer to be analyzed. Checking mouth tissue samples under a microscope may also help detect abnormal cells. Diagnostic procedures, such as fluorescence and reflectance imaging, fluorescence spectroscopy imaging, and tissue samples, may help doctors detect pre-cancer or early cancer when it may be easier to treat.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare images of oral mucosa, obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation, to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression.

OUTLINE:

Participants' oral cavities are inspected by a clinician using a standard white light headlamp. Participants then undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging. Standard oral brush biopsies are also performed and examined microscopically. Participants may undergo repeated imaging procedures and biopsy during subsequent follow up visits.

Study Type

Interventional

Enrollment (Actual)

338

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects with premalignant lesion, or potentially premalignant lesion, of the oral cavity mucosa (leukoplakia or erythroplakia)
  • Patients with a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease
  • Persons with any other condition (such as lichen planus, Fanconi anemia, heavy tobacco use, etc) making them at higher risk for oral cancer development
  • Patients with either pre-malignant or a history of oral cancer based on patient history and clinical presentations

Exclusion Criteria:

  • Subjects under the age of 18.
  • Subjects that are unable or unwilling to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (fluorescent/reflectance imaging, spectroscopy)
Participants' oral cavities are inspected by a clinician using a standard white light headlamp. Participants then undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging. Standard oral brush biopsies are also performed and examined microscopically. Participants may undergo repeated imaging procedures and biopsy during subsequent follow up visits.
Other: Cytology Specimen Collection Procedure
Undergo oral tissue collection
Other Names:
  • Cytologic Sampling
Procedure: Diagnostic Microscopy
Mouth tissue examined microscopically for cytologic features
Procedure: Diagnostic Procedure
Undergo standard white light headlamp oral examination
Other Names:
  • Diagnostic Method
  • Diagnostic Technique
  • Diagnostic Test
Procedure: Fluorescence Imaging
Undergo widefield fluorescent and reflectance imaging
Procedure: Fluorescence Spectroscopy
Undergo point fluorescent spectroscopy
Other Names:
  • Spectroscopy, Fluorescence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesions diagnosed via wide-field fluorescence imaging
Time Frame: Up to 10 years
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test. Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
Up to 10 years
Lesions diagnosed via point spectroscopy system
Time Frame: Up to 10 years
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test. Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
Up to 10 years
Lesions diagnosed via non-invasive brush cytology
Time Frame: Up to 10 years
Oral mucosa obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation will be compared to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. Diagnostic methods will be compared with each other by forming 2x2 tables and computing the chi-square statistics for the McNemar test. Kappa statistic will also be calculated for comparing the chance corrected agreement between various diagnostic methods.
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ann M Gillenwater, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2007

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria

October 10, 2007

First Posted (Estimated)

October 11, 2007

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-0802 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2015-01903 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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