# Real-time volumetric specimen imager for 3D intra-operative lumpectomy margin assessment

> **NIH NIH R44** · CLARIX IMAGING CORPORATION · 2020 · $1,757,967

## Abstract

Abstract
Clarix Imaging, Corporation (Clarix) is focused on solving one of the largest problems in early stage breast
cancer treatment, reoperations for positive margins. About 25% of the >200,000 patients who undergo
lumpectomy in the US each year will face this additional procedure because current options for identifying
positive margins intraoperatively are insufficient. Currently physicians rely on 2D specimen imaging for
assessing margin status during surgery which cannot adequately represent the 3D margin morphology of the
tumor. Therefore, Clarix is developing a novel volumetric specimen imager, VSI, device that yields fully 3D
images of the specimen with isotropic resolution which can significantly improve margin assessment and
provide precise guidance for directed cavity shaves before closing wound. In Phase I, we demonstrated the
ability of our VSI patented algorithms to overcome long scan times of conventional 3D imagers that would
disrupt surgical in a 20-case retrospective pilot study. In Phase II, we developed a robust prototype with
hardware designed for user ease of use and safety, and software for user-friendly OR workflow integration.
This transfer to manufacturing ready prototype was further validated in a large-scale 230 patient retrospective
study. An initial FDA 510(k) application for the VSI device resulting from Phase II will be submitted in Q3 2019.
We now propose four specific aims for a Phase IIB project that will help Clarix bridge the gap between
technology development and commercialization as follows. Aim 1, “Develop Software for Further Improved
Clinical Workflow and Radiology-Pathology Image Database” will further streamline integration into leading
Electronic Medical Record systems, and a database will be developed which will pair VSI data and digital
pathology records. Aim 2: “Develop Manufacturing Process for the VSI Device” for large scale manufacturing
ability. Aim 3: “Prospective Phase II Clinical Trial” a multi-center single-arm 100 patient clinical trial will be
conducted to preliminarily evaluate the ability of the VSI device to decrease positive margin rates to 10%. Aim
4: “Pivotal Randomized Clinical Trial” this 600 patient Phase III trial will be designed to definitively determine
improvement in negative margins to 90%, demonstration of superiority over the current standard in this study
will allow for specific FDA approval of FDA for margin assessment and widespread adoption. The 6,000 US
hospitals and clinics performing lumpectomy are incentivized to adopt VSI under the ongoing movement
toward value-based reimbursement, forming a ~$720M initial US installed-base. Our global market is
estimated at ~$4B. At the conclusion of Phase IIB we will prove the commercial viability regionally, and then
we will scale nationally and internationally.

## Key facts

- **NIH application ID:** 9994014
- **Project number:** 2R44CA206801-04
- **Recipient organization:** CLARIX IMAGING CORPORATION
- **Principal Investigator:** Xiao Han
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,757,967
- **Award type:** 2
- **Project period:** 2016-09-01 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9994014

## Citation

> US National Institutes of Health, RePORTER application 9994014, Real-time volumetric specimen imager for 3D intra-operative lumpectomy margin assessment (2R44CA206801-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9994014. Licensed CC0.

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