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.
Adult subjects with oral lesions undergoing surgical resection (i.e., only patients who are scheduled to undergo a surgery of the head & neck area to remove or biopsy oral lesions will be eligible to participate in the study); patients with previous treatment are eligible
Ability to understand and the willingness to sign a written informed consent document (ICD)
Known allergy to proflavine or acriflavine
Pregnant or nursing females
The participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol
Single group
High-Resolution Microendoscopy
Procedure/SurgeryUndergo evaluation of oral lesions using a high-resolution microendoscope
Multispectral Imaging
Procedure/SurgeryUndergo evaluation of oral cavity using a widefield multispectral imaging
Proflavine
DrugProflavine) used to stain the mouth tissue after initial imaging.
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.
Classification of tissue
Classification algorithms will be developed to separate imaged tissue into 2 diagnostic categories: normal non-neoplastic mucosa vs. dysplasia and cancer
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.
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.
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
