Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

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.

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.