# Quantitative Ultrasound Imaging Biomarkers of Crohn's Disease

> **NIH NIH R01** · MAYO CLINIC ROCHESTER · 2020 · $427,438

## Abstract

PROJECT SUMMARY
Crohn's Disease (CD), a chronic inflammatory bowel condition, affects over 1 million Americans and costs
billions of dollars annually. Frequent and accurate evaluation of bowel inflammation and fibrosis is critical to
guide therapy. Ultrasound is safe, cost-effective, and widely available, thus provides an attractive alternative to
contrast enhanced CT/MRI for frequent follow-ups. Here we propose a multi-parameter ultrasound imaging
approach combining B-mode, VesselQuest (a new microvessel imaging method with much higher sensitivity
than conventional Doppler), and Comb-push Ultrasound Shearwave Elastography (CUSE) for comprehensive
evaluation of CD inflammation and fibrosis burden.
Specific Aim 1: Technical Advancement. Synthetic Transmit Aperture imaging with coded virtual sources will
be used to improve the resolution and penetration of the high definition version VesselQuestHD. Random
Singular Value Decomposition (SVD) and randomized spatial down-sampling will be used to accelerate SVD
for realtime VesselQuestRT imaging. We will improve CUSE with marching push beams for shear wave
generation, and harmonic imaging for shear wave detection. Pilot patient tests will be conducted to optimize
these technologies and pave the way for clinical studies below.
Specific Aim 2: Comparison with MRI. We will study 100 CD patients to investigate efficacy of this new
technology for disease evaluation and treatment outcome prediction. Patients starting a new medical therapy
will have contrast enhanced MRI (used as reference standard) at baseline and 6-months post therapy, and
ultrasound at baseline, 4-weeks, and 6-months. The correlation of ultrasound parameters with MRI scores at
baseline and 6-months will be assessed. The efficacy of ultrasound for differentiating mild vs. severe disease
will be assessed by ROC (Receiver Operating Characteristic) analysis. In addition, ROC analysis will be used
to assess whether ultrasound parameters at baseline or 4-weeks can predict treatment response at 6-months.
Specific Aim 3: Reproducibility Study. Two sonographers will repeatedly scan 45 CD patients. Intraclass
correlation coefficients will be used to evaluate the inter-sonographer agreement for ultrasound parameters.
The within patient variance component from the model will provide an estimate of the inter-sonographer
variance, which represents a lower bound for the minimum detectable difference for longitudinal follow-ups.
Specific Aim 4: Comparison with Surgical Pathology. We will study 50 CD patients to investigate the
efficacy of this new technology for evaluating fibrosis, using surgical pathology as the reference standard. The
association of ultrasound parameters with fibrosis category obtained from pathology will be assessed using
Spearman rank correlation. In addition, ROC analysis will be used to assess whether individual or combined
ultrasound parameters can distinguish between none-to-moderate versus severe fibrosis.
Successful completion o...

## Key facts

- **NIH application ID:** 9888380
- **Project number:** 5R01DK120559-02
- **Recipient organization:** MAYO CLINIC ROCHESTER
- **Principal Investigator:** David Henry Bruining
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $427,438
- **Award type:** 5
- **Project period:** 2019-03-11 → 2022-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9888380

## Citation

> US National Institutes of Health, RePORTER application 9888380, Quantitative Ultrasound Imaging Biomarkers of Crohn's Disease (5R01DK120559-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9888380. Licensed CC0.

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