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NCT Number: NCT00542373

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

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.

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Key information

Conditions

Erythroplakia Anemia Anemia, Aplastic Anemia, Hypoplastic, Congenital Bone Marrow Diseases Bone Marrow Failure Disorders Chemically-Induced Disorders Congenital Bone Marrow Failure Syndromes Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Erythroplasia Fanconi Anemia Genetic Diseases, Inborn Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Leukokeratosis, Hereditary Mucosal Lichen Planus Lichenoid Eruptions Mental Disorders Metabolic Diseases Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Oral Cavity Leukoplakia Oral Cavity and Lip Precancerous Condition Oral Neoplasm Precancerous Conditions Premalignant Lesion Skin Diseases Skin Diseases, Genetic Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytology Specimen Collection Procedure

Other

Undergo oral tissue collection

Other names: Cytologic Sampling

Diagnostic Microscopy

Procedure

Mouth tissue examined microscopically for cytologic features

diagnostic procedure

Procedure

Undergo standard white light headlamp oral examination

Other names: Diagnostic Method, Diagnostic Technique, Diagnostic Test

fluorescence imaging

Procedure

Undergo widefield fluorescent and reflectance imaging

Fluorescence Spectroscopy

Procedure

Undergo point fluorescent spectroscopy

Other names: Spectroscopy, Fluorescence

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Fluorescence & Reflectance Imaging to Detect Oral Neoplasia

Important dates

Study start
2007
Primary completion
2027
Study completion
2027
First posted
Oct 11, 2007
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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