# Diffusion Histology Imaging: A Clinical Tool to Non-Invasively Diagnose and Manage Prostate Cancer

> **NIH NIH R01** · WASHINGTON UNIVERSITY · 2022 · $543,161

## Abstract

PROJECT SUMMARY
There are clear limitations to the current approach to prostate cancer (PCa) diagnosis. Approximately half of
the men who undergo a transrectal prostate biopsy—an extremely uncomfortable, invasive procedure with
significant risk including sepsis—are not found to have PCa. For those who have PCa, many have indolent
cancers that are best managed with active surveillance (AS), which requires annual repeat biopsies due to a
lack of accurate noninvasive tools. Biomarkers and prostate magnetic resonance imaging (MRI) have been
increasingly used to attempt to address this problem. However, the currently available tools are not accurate
enough alone or in combination to forgo biopsy.
We have developed a new MRI sequence (diffusion basis spectrum imaging) and a method of analyzing these
imaging metrics—diffusion histology imaging (DHI)—that may overcome the limitations of conventional MRI
interpretation. Preliminary data demonstrates high accuracy of DHI to predict prostate biopsy results
(presence of cancer and grade of cancer when present). We aim to apply DHI to patients in two distinct clinical
settings: Aim 1, initial biopsy for PSA screening, and Aim 2, repeat biopsy for known indolent PCa managed
with AS. We also plan for Aim 3 to update our DHI model based on the data obtained in these aims, then
recruit and test the updated DHI model in an independent group of patients undergoing PSA screening. We
hypothesize that DHI will allow for accurate and non-invasive diagnosis of PCa, and thus reduce unnecessary
biopsies.
In our proposed studies, the men will have had biomarker testing, then receive a clinical prostate MRI
(conventional sequences) with the DBSI imaging protocol added onto it prior to biopsy. The DBSI imaging will
be analyzed post-acquisition by our DHI model. Note that the DBSI protocol will add just a few minutes to the
total duration of the clinical MRI and will not significantly impact the patient or the clinical imaging workflow. In
parallel to conventional MRI interpretation and biopsy per clinical care, our team will perform DHI analysis on
the MRI images. By comparing DHI to biomarkers and conventional MRI against the histopathologic gold
standard (biopsy) in a prospective manner, we will determine if DHI can be used to noninvasively diagnose and
monitor PCa; therefore, supporting the clinical translation of DHI to be used as an alternative to invasive
biopsies.

## Key facts

- **NIH application ID:** 10364097
- **Project number:** 1R01CA258690-01A1
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** Joseph Edward Ippolito
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $543,161
- **Award type:** 1
- **Project period:** 2022-01-01 → 2026-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10364097

## Citation

> US National Institutes of Health, RePORTER application 10364097, Diffusion Histology Imaging: A Clinical Tool to Non-Invasively Diagnose and Manage Prostate Cancer (1R01CA258690-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10364097. Licensed CC0.

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