This project uses a novel magnetic resonance imaging (MRI) phantom object which recently underwent extensive development and preliminary testing with the support of VA funding. The phantom has now demonstrated the ability to accurately measure various MRI parameters (including diffusion measures which can be difficult to assess); it has been used to test important differences that occur across scanners and to develop methods to correct for these differences.

The phantom design has now been optimized and is ready to progress to a commercial product and to be deployed at a large scale. The Universal Phantom is designed to cover a wide range of MRI measurements, including measurement of parameters that are important in conventional imaging, but also novel measurements of diffusion imaging and other more advanced sequences. The phantom has been designed to be easy to use and can be utilized with all existing clinical scanner equipment, with additional preliminary models for high-field animal and research scanners.

In addition to development of the phantom itself to a market-ready product, the project includes aims that address automated analysis and reporting of the phantom data for rapid detection and improvement of issues that are detected with the scanner. Finally, the phantom will compose an element of a larger quality assurance system that will greatly enhance both clinical and research imaging. As no such comprehensive quantitative assessment and automatic reporting service exists for MRI at this time, this represents a critical step in 1) optimizing imaging sequences which are currently used in clinical practice and 2) overcoming obstacles that now limit the use of many quantitative imaging methods that could greatly enhance diagnosis, monitoring, and treatment planning for our Veterans.

1. Collect Quantitative Quality Assurance (QQA) data from MRI scanners in calendar years 2019-2021 on VA and leading academic centers. This will enable quantification of accuracy and stability of current brain imaging and allow initial implementation of methods to minimize and remove systematic error.

2. Finalize design of a high-quality, robust, modular, universal brain phantom, which includes an anisotropic disc, an isotropic disc, a spatial homogeneity disc, a heating mechanism to scan the phantom at human body temperature, a lipid layer around the dome, a 1-year warranty, and a 1-year software license for data storage and report generation. The anisotropic diffusion disc contains textile fibers that are at the scale of human axons, allowing for more precise measurement of diffusion properties.

3. Inventory and create database of current VA brain imaging protocols used at VA hospitals at participating sites. This will enable VA centers to share, test and select existing MRI protocols for clinical imaging, and also to further optimize clinical and research protocols using data collected as part of the project.

4. Provide software to automatically analyze phantom data, provide site-specific QQA reports, provide problem alerts, and support cross-instrument correction of metrics. This enhances the accuracy and consistency of MRI measurement and enables the collection of robust normative data.

5. Establish a centralized brain imaging support office within the VA that would provide training, QQA assessments, recommended protocols, and trouble-shooting assistance.6. Assess clinical diagnostic value to patients with differing degrees of injury or disease to assess of optimized and well-calibrated scans relative to current standard-of-care imaging; this would be accomplished through a blinded clinical read trial.