An interventional study of High-Resolution Microendoscopy and Multispectral Imaging in Oral Cavity Neoplasm, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Diagnostic
This clinical trial studies wide-field and high resolution in vivo imaging in visualizing lesions in patients with abnormal or uncontrolled oral cell growth (neoplasia) undergoing surgery. Diagnostic procedures, such as wide-field and high resolution in vivo imaging, are devices that let researchers look at a wide area of the lining of the mouth by shining different colors inside the mouth and taking pictures and this may help doctors to decide if a mouth lesion has a high risk of being pre-cancerous or cancerous.
PRIMARY OBJECTIVES:
I. To evaluate the feasibility for assessing oral mucosa in vivo with wide-field and high resolution images obtained using new optical imaging devices composed of cameras and microscopes, and with a topically administered contrast agent.
II. To develop and evaluate algorithms to classify tissue as normal (including hyperkeratosis, hyperplasia, and inflammation) or abnormal (any grade of dysplasia or cancer) based on quantitative parameters extracted from the optical images.
SECONDARY OBJECTIVES:
I. To determine the percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye.
II. To identify qualitative and quantitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions.
OUTLINE:
Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (high-resolution microendoscope [HRME]) at baseline, after induction of general anesthesia, and prior to surgery.
After completion of study, patients are followed up for 3 months.
377 studies on the registry are indexed under Mouth Neoplasms; 126 are open to participants now.
This study's planned enrollment of 275 is above the median of 65 across 265 interventional studies indexed under Mouth Neoplasms.
Browse Mouth Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (HRME) at baseline, after induction of general anesthesia, and prior to surgery.
Procedure: High-Resolution Microendoscopy · Procedure: Multispectral Imaging · Drug: Proflavine
Undergo evaluation of oral lesions using a high-resolution microendoscope
Also known as: HRME
Undergo evaluation of oral cavity using a widefield multispectral imaging
Proflavine) used to stain the mouth tissue after initial imaging.
Also known as: Proflavine hemisulfate
Evaluation of oral mucosa to be used for non-invasive detection and diagnosis with the use of optical imaging after administration of the topical contrast agent proflavine.
Images obtained will be compared against the histology slides of tissue taken from the same region.
Time frame: 1 day
Classification of tissue
Classification algorithms will be developed to separate imaged tissue into 2 diagnostic categories: normal non-neoplastic mucosa vs. dysplasia and cancer
Time frame: 1 day
Percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye
The data analysis will be descriptive and exploratory in nature. The potential association between sites within the same subject will be examined as well. Performance will be characterized in terms of sensitivity, specificity, area under the ROC curve, and classification accuracy within each diagnostic category.
Time frame: 1 day
Qualitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions
Performance will be characterized in terms of sensitivity, specificity, area under the ROC curve, and classification accuracy within each diagnostic category.
Time frame: 1 day
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M.D. Anderson Cancer Center