# A Volumetric-Imaging Software Platform for Enabling Optimized Workflow of Multidisciplinary Lumpectomy Assessment

> **NIH NIH R43** · CLARIX IMAGING CORPORATION · 2020 · $224,950

## Abstract

Project Summary
Clarix Imaging (CI) is a startup medical device company spun out of The University of Chicago (UC) to develop
a real-time X-ray volumetric specimen imager (VSI) device and software solution for enabling accurate and
rapid 3D margin assessment (MA) in the operating room (OR) and pathology laboratory. We propose this SBIR
Phase I research to establish the feasibility of a VSI-based software platform for enabling multidisciplinary
workflows for lumpectomy assessment, which lays the foundation for optimizing an innovative, user-friendly
workflow with optimized MA accuracy and efficiency for routine clinical application. The annual performance of
>200,000 outpatient breast lumpectomies in the US has a high reoperation rate (25%). Meanwhile, no tumor is
found in up to 63% of these reoperations, resulting in simultaneous over-treatment of unnecessary healthy
tissues and under-treatment as tumor may remain in the patient’s breast. A leading cause of this problem is the
high discordance among surgeons, radiologists, and pathologists on specimen orientation due to the lack of
adequate tools facilitating their collaboration in the existing MA workflow. The current practice relies on
surgeon’s sutures, specimen radiographs, and pathologist’s inking to localize positive margin (PM). Studies
showed that the discordance rate on PM location among surgeons, radiologists, and pathologists range from
31% to 52%. There is an unmet need for an improved workflow yielding better agreement among the
multidisciplinary team. Recently, CI developed the VSI device for real-time full 3D lumpectomy specimen
imaging in the OR. The availability of VSI provides the foundation for innovative software platform and
applications that can enable better multidisciplinary workflows for lumpectomy assessment. The product of this
SBIR will be a software platform that allows real-time, remote shared visualization and annotation of full 3D VSI
images by multiple users. The software will also enable virtual inking by the surgeon to communicate a precise
specimen orientation across the entire multidisciplinary team. We envision in the next 3-4 years to introduce
the proposed software platform as the standard clinical workflow, and together with the VSI device, they
complete the CI solution for lumpectomy MA. The Specific Aims of the Phase I project are (1) to create and
validate the software platform for shared multi-user visualization of VSI data, and (2) to create and verify the
virtual inking application for enabling optimized MA workflow. Reaching these Aims will firmly establish the
feasibility of using the proposed VSI-based software platform to enable optimized multidisciplinary MA
workflow, and reduce the technical risk of Phase II work, which includes (1) optimizing the software platform
cybersecurity and robustness within a hospital network environment, (2) fully developing the virtual inking
technique optimally integrated in the clinical workflow integration, and (...

## Key facts

- **NIH application ID:** 10011691
- **Project number:** 1R43CA250939-01
- **Recipient organization:** CLARIX IMAGING CORPORATION
- **Principal Investigator:** Christian Wietholt
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $224,950
- **Award type:** 1
- **Project period:** 2020-05-01 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10011691

## Citation

> US National Institutes of Health, RePORTER application 10011691, A Volumetric-Imaging Software Platform for Enabling Optimized Workflow of Multidisciplinary Lumpectomy Assessment (1R43CA250939-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10011691. Licensed CC0.

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