Award

Temperature-controlled spherical magnetic resonance imaging phantom

Image-calibration technology designed and developed by Michael Boss at the National Institute of Standards and Technology (NIST) and commercialized by Elizabeth Mirowski at High Precision Devices, Inc. (HPD) has been adopted for use in multi-site clinical trials in the United States and Europe to study the effects of traumatic brain injury (TBI). About two dozen of the units, which were brought from conceptualization to commercialization in only a year, will be distributed to trial participants in an effort to bring uniform quality control to a critically important brain imaging technique.

Magnetic resonance imaging (MRI) is the principal diagnostic tool for detecting and monitoring microscopic changes caused by TBI. But MRI scanners are made by several manufacturers, operated in a variety of clinical settings, and generate images using different values for key parameters. To ensure that brain and other scans are not only accurate but also comparable to images of the same patient taken at different times or to images made on other scanners, physicians need a quantitatively consistent standard against which to calibrate their instruments.

In response to requests from clinicians, NIST conceptualized and made prototypes of a head ?phantom? (calibration standard), a spherical plastic shell the size of a volleyball. It is filled with containers of polymer solutions at various, carefully prepared concentrations. These serve as standard surrogates for water having different rates of diffusion in the brain. Water diffusion is a major indicator of injury in TBI, and it can be used to reveal conditions that otherwise would be invisible. The phantoms are cooled by an ice-water bath system so different users will all make measurements of the same property of interest at the same temperature, 0°C, eliminating the measurement variability caused by temperature differences across MRI scanners.

The technology also has utility beyond TBI, and is adaptable to various kinds of imaging in cancer and neurotrauma, as well as the study of neurodegenerative diseases. Initial prototypes of the phantoms were developed in collaboration with the National Cancer Institute and the Radiological Society of North America's Quantitative Imaging Biomarker Alliance. The prototypes were then circulated for testing and evaluation to European Union collaborators in the Innovative Medicines Initiative Quantitative Imaging in Cancer: Connecting Cellular Processes with Therapy (IMI-QuICConCePT) initiative, who expressed interest in using the phantom for quality control in clinical trials for cancer. In 2014, an American TBI clinical trial called TRACK-TBI, supported by the National Institutes of Health, received its prototype copy, leading to an order of phantoms for each site in the trial. This technology transfer has led to tremendous consumer demand, which is being met by an American manufacturer, High Precision Devices, Inc. The use of the phantom will facilitate quantitative MRI data acquisition, and ultimately lead to more cost-effective healthcare and improved quality of life for Americans.

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Region: 
Mid-Continent