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

Tobacco Use Disorder Clinical Trial

Official title:

Fluorescence &Amp; Reflectance Imaging to Detect Oral Neoplasia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00542373
• Other study ID #: 2006-0802
• Secondary ID: NCI-2015-0190320
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 27, 2007
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 338
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Cytology Specimen Collection Procedure
Undergo oral tissue collection

Procedure:
• Diagnostic Microscopy
Mouth tissue examined microscopically for cytologic features
• Diagnostic Procedure
Undergo standard white light headlamp oral examination
• Fluorescence Imaging
Undergo widefield fluorescent and reflectance imaging
• Fluorescence Spectroscopy
Undergo point fluorescent spectroscopy

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesions diagnosed via wide-field fluorescence imaging	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
Primary	Lesions diagnosed via point spectroscopy system	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
Primary	Lesions diagnosed via non-invasive brush cytology	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

External Links

•   University of Texas MD Anderson Cancer Center Website