# MDCT Quantification of hepatic tumor viability for assessment of cancer therapy

> **NIH NIH SB1** · IQ MEDICAL IMAGING, LLC · 2021 · $240,583

## Abstract

Project Summary / Abstract
Tumor imaging quantification is critical for cancer diagnosis, staging, and treatment evaluation,
and multi-detector CT (MDCT) is the clinical imaging modality commonly used for patients
diagnosed with hepatic malignancy because of its relatively low cost and wide availability.
Conventional tumor quantification using either linear or volumetric measurement has
demonstrated significant limitations in the evaluation of malignant liver tumors such as for
hepatocellular carcinoma (HCC) when being treated with targeted antiangiogenic therapies or
locoregional therapies because changes in overall tumor size do not necessarily reflect
tumor response to therapy. This leads to an unmet clinical demand to develop a functional
tumor quantification biomarker (QIB), for effective and accurate assessment of treatment
response for liver cancer patients. In the phase II project, we developed a hepatic tumor viability
(HTV) QIB for automated quantification of tumor viability of HCC using contrast-enhanced multi-
phase hepatic MDCT images and transferred the HTV technology to IQ Medical Imaging’s
Advanced Tumor Quantification Imaging (ATIQ) Software as Medical Device (SaMD) with an FDA
Compliant Quality Management System (QMS), and evaluated it using MDCT datasets of 200
patients with advanced HCC treated with antiangiogenic therapies and trans-arterial
chemoembolization (TACE) therapies collected at MGH Cancer Center.
In the CRP project, we propose three specific aims: (1)FDA 510(k) clearance and post-market
surveillance of ATIQ SaMD: We will develop an FDA 510(k) strategy, prepare submission
materials and complete the FDA 510(k) submission using expert consultants; Obtaining FDA
510(k) clearance with submission support; and implement a post-market surveillance strategy.
(2) Development of commercialization strategy for ATIQ: we will perform an in-depth market
research analysis for the US and global market with expert consultants; and develop a
comprehensive business plan addressing funding and commercialization options; and (3)
Development of Intellectual Property (IP) and Licensing Strategy for ATIQ: employing consultants
with licensing expertise, we will complete the IP licensing agreement with Partners HealthCare
related to the original algorithms and software to be used in ATIQ; and develop a comprehensive
IP strategy for licensing and protection of ATIQ technologies. Successful completion of the CRP
will deliver this clinically impactful HTV technology as an FDA approved ATIQ SaMD providing an
effective and accurate tumor quantification tool compared to conventional size-based methods
for reliable assessment of tumor progression and treatment response for patients with HCC.

## Key facts

- **NIH application ID:** 10139802
- **Project number:** 2SB1CA189637-04
- **Recipient organization:** IQ MEDICAL IMAGING, LLC
- **Principal Investigator:** Yin Wu
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $240,583
- **Award type:** 2
- **Project period:** 2014-09-16 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10139802

## Citation

> US National Institutes of Health, RePORTER application 10139802, MDCT Quantification of hepatic tumor viability for assessment of cancer therapy (2SB1CA189637-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10139802. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*