# MRI Virtual Pathology of the Prostate: Multi-center multi-vendor application and validation

> **NIH NIH UT2** · QMIS, LLC · 2022 · $1,024,503

## Abstract

PROJECT SUMMARY
The U.S. Preventative Task Force found current ultrasound-based screening methods unreliable, causing
unnecessary biopsies and failing to detect clinically significant Prostate Cancer (PCa) in patients with an elevated
prostate-specific antigen (PSA). Millions of men in the U.S. alone are currently at elevated risk for PCa, but there
are no effective alternatives for screening. Although MRI as a second-line screening and screening of high-risk
men is gradually increasing, MRI sensitivity and specificity are currently inadequate for large-scale clinical use.
Thus, there is a critical need for new and more accurate non-invasive approaches to guide the biopsies for
confirming PCa.
Quantitative MRI Solutions (QMIS), LLC has developed MR Virtual Pathology of the Prostate (MVP2) – a new
quantitative MRI analysis and interpretation software tool for PCa screening and diagnosis. MVP2 uses
compartmental analysis of hybrid-multidimensional MRI (HM-MRI) data to quantify volume fractions of three
tissue spaces: lumen, stroma, and epithelium. This provides novel HM-MRI-based markers of PCa as high
epithelial and low stromal and luminal fractions indicate PCa. In our previously funded NCI Phase I STTR, we
accomplished all technical and logistical R&D goals. Specifically, we successfully developed and optimized the
underlying compartment model to maximize agreement between MVP2 and the gold standard quantitative
histology as well as evaluation of tissue composition by expert pathologists. We demonstrated the accuracy of
MVP2 compared with clinical evaluation based on Prostate Imaging Reporting and Data System (PIRAD). In
addition, we developed and tested a user-friendly interface for the efficient execution of our software. Our
software solution is consistent with FDA requirements. The outcome of Phase I is the proven feasibility of MVP2
software for clinical screening and diagnosis of PCa.
The goals of this Phase II proposal include a) ensure successful commercialization at scale by developing and
testing a cloud-based MVP2 that works with leading MRI scanner brands, b) demonstrate the clinical efficacy of
MVP2 for guiding biopsy via multicenter clinical trial, and c) demonstrate that MVP2 works with scanners from
the 3 major manufacturers. The results from Phase II will provide strong evidence for the clinical efficacy of PCa
screening with MVP2’. This will make QMIS highly competitive in the vast market for PCa screening. MVP2 will
help to improve outcomes for millions of men at risk of PCa, leading to reduced misdiagnosis and overtreatment,
increased survival due to early detection, and effective screening even with sub-optimal physician training.

## Key facts

- **NIH application ID:** 10482652
- **Project number:** 2UT2CA244056-02
- **Recipient organization:** QMIS, LLC
- **Principal Investigator:** Aritrick Chatterjee
- **Activity code:** UT2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,024,503
- **Award type:** 2
- **Project period:** 2020-04-01 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10482652

## Citation

> US National Institutes of Health, RePORTER application 10482652, MRI Virtual Pathology of the Prostate: Multi-center multi-vendor application and validation (2UT2CA244056-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10482652. Licensed CC0.

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