NCT00542373

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

Fluorescence & Reflectance Imaging to Detect Oral Neoplasia

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Erythroplakia
• Fanconi Anemia
• Lichen Planus
• Oral Cavity and Lip Precancerous Condition
• Oral Cavity Leukoplakia
• Oral Neoplasm
• Premalignant Lesion
• Tobacco Use Disorder

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Undergo oral tissue collection
PROCEDURE	Diagnostic Microscopy	Mouth tissue examined microscopically for cytologic features
PROCEDURE	Diagnostic Procedure	Undergo standard white light headlamp oral examination
PROCEDURE	Fluorescence Imaging	Undergo widefield fluorescent and reflectance imaging
PROCEDURE	Fluorescence Spectroscopy	Undergo point fluorescent spectroscopy

Timeline

• Start date: 2007-08-27
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2007-10-11
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States