Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

Study Overview
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Brief Summary
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This early phase I trial studies how well multimodal imaging works for surveillance in patients with oral potentially malignant disorders. New types of imaging devices may help doctors decide if a lesion in the mouth is pre-cancerous or cancerous.

Detailed Description
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PRIMARY OBJECTIVES: I. To compare standard white light examination to multimodal imaging for detection of high grade dysplasia and carcinoma during follow-up examinations of patients with oral potentially malignant disorders (OPMD). SECONDARY OBJECTIVES: I. To determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality. II. To compare expression of molecular biomarkers to results from white light examination, multimodal imaging and pathologic assessment in a subset of patients who have invasive biopsies or resection. III. To compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results. OUTLINE: Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years. After completion of study treatment, patients are followed up at 30 days.

Official Title
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Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders

Conditions
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Dysplasia, Lip and Oral Cavity Carcinoma, Oral Disorder, Premalignant Lesion

Intervention / Treatment
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* Procedure: Biopsy
* Procedure: Fluorescence Imaging
* Procedure: High-Resolution Microendoscopy
* Drug: Proflavine Hemisulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are willing to participate. Adult subjects with: a. clinically evident oral premalignant lesion (OPL) or suspicious oral mucosal lesion. or b. pathologic diagnosis of dysplasia or c. history of resected oral cancer or d. oral potentially malignant disorder (OPMD) or e. history of tobacco and/or alcohol exposure. Ability to understand and willingness to sign a written informed consent document (ICD). Exclusion Criteria: Known allergy to proflavine or acriflavine. Pregnant females.

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: Diagnostic (multimodal imaging, biopsy)<br>Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years. | Procedure: Biopsy<br>* Undergo brush biopsy and incisional biopsy<br>* Other names: Bx;Procedure: Fluorescence Imaging<br>* Undergo PS2.1/PS3 imaging<br>Procedure: High-Resolution Microendoscopy<br>* Undergo HRME imaging<br>* Other names: HRME;Drug: Proflavine Hemisulfate<br>* Applied on mucosa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of high grade dysplasia and carcinoma | Will compare standard white light examination to multimodal imaging for detection of high grade dysplasia and carcinoma during follow-up examinations of patients with oral potentially malignant disorders (OPMD). | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic assessment | Will determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality. | Up to 2 years | 
| Biomarker analysis | Will compare expression of molecular biomarkers to results from white light examination, multimodal imaging and pathologic assessment in a subset of patients who have invasive biopsies or resection. | Up to 2 years | 
| Cytologic results | Will compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results. | Up to 2 years |