# 3D optical histopathology for head and neck intraoperative consultation.

> **NIH NIH R44** · OPSICLEAR LLC · 2024 · $1,002,315

## Abstract

Project Summary
Intraoperative consultations (IOC, often refers to frozen-section histopathology during surgery) significantly
improve the outcome of many oncological surgeries. However, even though this procedure generates results
much faster than traditional formalin-fixed paraffin-embedded (FFPE) histopathology, it is still lengthy for time-
sensitive surgeries such as head and neck tumor resections. Surgeries often need to be paused during the IOC,
leading to an expensive waste of operating room time and resources. Because IOC usually requires a fast
turnaround, only a few slices can be prepared and evaluated at a time. Miscommunication between surgeons
and pathologists leads to sampling errors. Freezing artifacts result in degraded histology quality. These
limitations increase the risk of missing important histopathology information in the slice, resulting in false-
negative margins which affects the success rate and long-term outcomes of cancer surgeries. Thus, there is a
need for faster and more reliable intraoperative histopathology evaluation. To address these limitations, we
propose to develop an alternative histology framework for intraoperative histopathology assessment using a
combination of optical clearing and 3D imaging technologies developed in our lab. Our proposed product will
provide 3D histology information of intraoperative specimens with a faster and simpler workflow than the
incumbent solution. The product comprises three major components: 1) a rapid tissue processing pipeline that
makes tissue transparent with a few washes, 2) a user-friendly imaging system that enables real-time 3D
microscopy imaging of the transparent whole-mount clinical specimens, 3) A software user interface that
translates the 3D data into 2D images with pathologist-familiar color contrast and assists the pathologist in
interpreting the data. 3D virtual histology has been proposed as an alternative to slice-based histopathology to
provide more accurate diagnoses. However, current 3D virtual histopathology techniques often have high
complexity and long turnaround time. Our preliminary customer discovery suggested it was highly challenging
for histology labs to incorporate these new techniques into the existing well-established workflow due to high
capital cost and complexity. By simplifying the sample preparation into 2-3 fluid washes and providing a plug-
and-play 3D imaging device that requires minimal calibration and maintenance, our product will enable 3D virtual
histopathology that is easier, faster, and more accurate than the traditional methods.

## Key facts

- **NIH application ID:** 11065582
- **Project number:** 4R44CA268156-03
- **Recipient organization:** OPSICLEAR LLC
- **Principal Investigator:** YEHE LIU
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,002,315
- **Award type:** 4N
- **Project period:** 2022-04-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11065582

## Citation

> US National Institutes of Health, RePORTER application 11065582, 3D optical histopathology for head and neck intraoperative consultation. (4R44CA268156-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11065582. Licensed CC0.

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