Precision Optical Guidance for Oral Biopsy

Study Overview
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Brief Summary
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To learn if a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.

Detailed Description
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Primary objective: -To evaluate and optimize the technical performance characteristics of an Active Biopsy Guidance System. Secondary objective: -To provide a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology. Optical imaging; optical projection of light onto tissue; optical contrast agent (proflavine).

Official Title
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Precision Optical Guidance for Oral Biopsy Based on Next-Generation Hallmarks of Cancer (1R01DE029590-01): A Clinical Study to Evaluate and Optimize the Technical Performance Characteristics of an Active Biopsy Guidance System

Conditions
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Oral Lesions

Intervention / Treatment
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* Device: High Resolution Microendoscope (HRME)
* Device: Optical Mapping Scope
* Drug: Proflavine hemisulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects with clinically evident oral lesions such as leukoplakia or erythroplakia, oral potentially malignant disorders (OPMD) such as lichen planus and graft vs. host disease, pathologic diagnosis of dysplasia, or a history of resected oral cancer, are eligible to participate. Patients with previous treatment including surgery, radiation, chemotherapy or other therapies are also eligible. Ability to understand and willingness to sign a written Informed Consent Document (ICD). Exclusion Criteria: Known allergy to proflavine or acriflavine. Age less than 18 years. Pregnant or nursing females. Adults unable to consent Prisoners and other vulnerable populations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Active Biopsy Guidance System<br>This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME): | Device: High Resolution Microendoscope (HRME)<br>* The High Resolution Microendoscope (HRME) take pictures of a very small area of the lining of the mouth, about the size of a pencil tip, but at high magnification.<br>Device: Optical Mapping Scope<br>* The optical mapping scope displays a wide area of the lining of the mouth (about the size of the top of a soda can) by shining different colors of light into the mouth and taking pictures.<br>Drug: Proflavine hemisulfate<br>* A coloring substance (a fluorescent dye which glows green in the dark), called proflavine hemisulfate, will be painted on areas of the mouth with a cotton tip applicator to help improve the pictures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology |  | Through study completion an average of 1 year. |