# Precision Optical Guidance for Oral Biopsy Based on Next-Generation Hallmarks of Cancer

> **NIH NIH R01** · RICE UNIVERSITY · 2022 · $634,095

## Abstract

Project Summary/Abstract:
With over 300,000 new cases per year and a mortality rate of approximately 50%, oral cancer is a major global health
issue. The stage at diagnosis is the most important predictor of survival, and unfortunately, most patients are diagnosed
at a late stage. Oral cancer is preceded by visible mucosal changes which are designated oral potentially malignant
disorders (OPMD). Invasive biopsy of oral lesions is the gold standard to diagnose oral dysplasia and cancer, and
pathologic diagnosis of dysplasia is the best indicator of risk for oral cancer development. Dysplasia often arises in
patients with OPMDs; however, most practitioners lack expertise to distinguish OPMDs from benign lesions. It is difficult
even for experts to determine which oral lesions are at highest risk to contain dysplasia and should be biopsied. The goal
of this proposal is to develop and validate an Active Biopsy Guidance (ABG) optical imaging system, consisting of an
optical mapping scope and a high resolution microscope, to help clinicians determine precisely when and where to
biopsy suspicious oral lesions. The ABG system will integrate several optical imaging modalities to non-invasively probe
key molecular and morphologic changes associated with the next-generation hallmarks of cancer.
In Aim 1, we will develop a compact optical mapping scope that uses Digital Light Processing technology to capture
white light and auto-fluorescence images and actively project onto the oral mucosa a map highlighting areas at high risk
for oral dysplasia and cancer based on loss of collagen fluorescence (a signal of invasion and metastasis) and alterations
in epithelial NAD(P)H and FAD fluorescence (a signal of de-regulated cellular energetics). The mapping scope will
function as the first step in the image guidance sequence, projecting a visible map of high-risk regions on the oral tissue.
We will develop tracking algorithms to adjust the projected map to ensure accurate positioning despite patient
movement. In Aim 2, we will develop a low-cost fluorescence and reflectance high resolution microscope capable of
imaging nuclear morphology in the oral epithelium (a signal of sustained proliferative signaling, genome instability and
mutation) and microvascular density and morphology (a signal of angiogenesis). The high resolution probe will serve as a
confirmation modality to improve specificity. In Aim 3, we will integrate the optical mapping scope and high resolution
microscope into a single, compact Active Biopsy Guidance system and validate its ability to provide real-time precise
guidance for selection of oral biopsy sites in a study of high-risk patients undergoing surveillance for oral cancer.
Combining widefield autofluorescence imaging and high resolution imaging of nuclear and microvessel morphology will
provide a biologically directed approach to help clinicians precisely determine where and when to biopsy suspicious oral
lesions, achieving both high sensitiv...

## Key facts

- **NIH application ID:** 10326402
- **Project number:** 5R01DE029590-03
- **Recipient organization:** RICE UNIVERSITY
- **Principal Investigator:** Ann M Gillenwater
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $634,095
- **Award type:** 5
- **Project period:** 2020-02-25 → 2025-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10326402

## Citation

> US National Institutes of Health, RePORTER application 10326402, Precision Optical Guidance for Oral Biopsy Based on Next-Generation Hallmarks of Cancer (5R01DE029590-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10326402. Licensed CC0.

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