Wide-Field and High Resolution In Vivo Imaging of Oral Neoplasia Using Topical Fluorescent Dyes: A Feasibility Study
M.D. Anderson Cancer Center
Summary
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.
Description
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 successf…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) Exclusion Criteria: * 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…
Interventions
- ProcedureHigh-Resolution Microendoscopy
Undergo evaluation of oral lesions using a high-resolution microendoscope
- ProcedureMultispectral Imaging
Undergo evaluation of oral cavity using a widefield multispectral imaging
- DrugProflavine
Proflavine) used to stain the mouth tissue after initial imaging.
Location
- M D Anderson Cancer CenterHouston, Texas