# Bimodal Intraoral imaging device for detection of oral epithelial neoplasia

> **NIH NIH R01** · UNIVERSITY OF TEXAS MED BR GALVESTON · 2022 · $496,758

## Abstract

ABSTRACT
The goal of this project is to develop a novel bimodal intraoral imaging device for assessment of the oral and
oropharynx mucosa for detection of neoplasia, aiding in early detection. Oral and oropharyngeal cancers account
for 640,000 new cases of cancer worldwide each year. The number of cases increases each year, in part due to
the spread of human papillomavirus. The 5-year survival rate has remained relatively unchanged over several
decades, despite accessibility of the oral cavity and oropharynx for examination. With early detection, the 5-year
survival rate increases to 80%, providing hope of improved patient outcomes given development of effective
early detection approaches. The current clinical approach of detection by visual examination with palpation to
guide biopsy acquisition, is insufficient to reliably detect neoplasia at the earliest, most treatable stages, including
oral epithelial dysplasia (OED) and early oral/oropharyngeal squamous cell carcinoma (OSCC). Our preclinical
and pilot clinical sample studies indicate that label-free nonlinear optical microscopy (NLOM), consisting of
multiphoton autofluorescence microscopy and second harmonic generation, is highly promising as an optical
biopsy method. It provides deep mucosal imaging at subcellular resolution and detects parameters associated
with neoplasia that parallel histology. In addition to optical histology, NLOM provides additional spectroscopic
metrics based on the metabolic and biochemical microenvironment, which may add to optical histology metrics.
Our results assessing NLOM for this application show high sensitivity and specificity for detection of neoplasia,
and a high degree of agreement with histopathology. Despite these advantages, a limitation of microscopy is the
inherently limited image field of view on the order of hundreds of microns. On the other hand, clinical large area
screening methods comprised of widefield autofluorescence (WF) imaging provide the fields needed
(centimeters) with high sensitivity for detection, but lack specificity and cannot image below the surface or assess
microscopic features. In this project, we will combine the benefits of both approaches into a single handheld
intraoral imaging device that will provide large area screening for regions of suspicion for neoplasia using WF
coupled with detailed, depth-resolved subsurface imaging by NLOM for highly sensitive and specific detection of
high risk lesions (OED) and early OSCC. To accomplish this goal we will 1) construct a biomodal WF-NLOM
intraoral imaging device and optimize performance and suitability for noninvasive evaluation of neoplasia in
human oral/oropharyngeal mucosa; 2) refine and translate methodology and metrics defined in preclinical
studies, to the intraoral device for use in human OSCC; and 3) evaluate the bimodal intraoral imaging device
performance and conduct a pilot study to evaluate the device in patients in vivo, obtaining valuable feedback
regarding potenti...

## Key facts

- **NIH application ID:** 10306325
- **Project number:** 5R01CA247595-03
- **Recipient organization:** UNIVERSITY OF TEXAS MED BR GALVESTON
- **Principal Investigator:** Xingde Li
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $496,758
- **Award type:** 5
- **Project period:** 2019-12-01 → 2024-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10306325

## Citation

> US National Institutes of Health, RePORTER application 10306325, Bimodal Intraoral imaging device for detection of oral epithelial neoplasia (5R01CA247595-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10306325. Licensed CC0.

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