# Image Analysis Tools for mpMRI Prostate Cancer Diagnosis Using PI-RADS

> **NIH NIH R42** · EIGEN HEALTH SERVICES LLC · 2021 · $803,082

## Abstract

Project Summary
Prostate cancer is one of the most commonly occurring forms of cancer, accounting for 21% of all cancer in men.
The Prostate Imaging Reporting and Data System (PI-RADS) aims to standardize reporting of prostate cancer
using multi-parametric magnetic resonance imaging (mpMRI). However, the in-depth analysis, as demanded
by PI-RADS, remains challenging due to the complexity and heterogeneity of the disease, and it is a clinically
burdensome task subject to both signiﬁcant intra- and inter-reader variability. Auxiliary tools based on machine
learning methods such as deep learning can reduce diagnostic variability and increase workload efﬁciency by
automatically performing tasks and presenting results to a radiologist for the purpose of decision support. In
particular, automated identiﬁcation and classiﬁcation of lesion candidates using imaging data can be performed
with respect to PI-RADS scoring. In Phase I of this project, we developed two automated methods to reduce the
intra- and inter-observer variability while interpreting mpMRI images using the PI-RADS protocol: (i) a method
to co-register mpMRI data, and (ii) a method to geometrically segment the prostate gland into the PI-RADS
protocol sector map. The overarching goal of this Phase II project is to develop machine learning algorithms that
incorporate both co-registered multi-modal imaging biomarkers and PI-RADS sector map information into an
automated clinical diagnostic aid. The innovation in this project lies in the use of deep learning to automatically
predict PI-RADS classiﬁcation. This project is signiﬁcant in that it has the potential to improve clinical efﬁciency
and reduce diagnostic variation in prostate cancer diagnosis. In Aim 1 of this project, we will develop a deep
learning approach to localize and classify lesions in mpMRI. In Aim 2, we will integrate this diagnostic tool into the
ProFuseCAD system and perform rigorous multi-site validation to quantify PI-RADS classiﬁcation performance.
Both aims will utilize a database of over 1,000 existing mpMRI images from multiple clinical sites to develop and
validate the algorithms. Ultimately, enhancements from this project will create a novel feature for Eigen's (the
applicant company's) FDA 510(k)-cleared imaging product, ProFuseCAD, in order to improve the diagnosis and
reporting of prostate cancer.

## Key facts

- **NIH application ID:** 10256757
- **Project number:** 5R42CA224888-04
- **Recipient organization:** EIGEN HEALTH SERVICES LLC
- **Principal Investigator:** John Aaron Onofrey
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $803,082
- **Award type:** 5
- **Project period:** 2018-05-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10256757

## Citation

> US National Institutes of Health, RePORTER application 10256757, Image Analysis Tools for mpMRI Prostate Cancer Diagnosis Using PI-RADS (5R42CA224888-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10256757. Licensed CC0.

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