Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery

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 successfully imaged with
wide-field and high-resolution optical microscopes after topical application of contrast dye.

II. To identify qualitative and quantitative features within images that differ between
pathologically normal, dysplastic, cancerous and inflammatory lesions.

OUTLINE:

Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and
a high-resolution optical system (high-resolution microendoscope [HRME]) at baseline, after
induction of general anesthesia, and prior to surgery.

After completion of study, patients are followed up for 3 months.

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 an agent is actively administered to the study subject), while
being imaged (on active treatment) on this protocol