Study opens new approach to integrate MRI in multisite pancreatic clinical trials

Researchers at Vanderbilt Diabetes Research and Training Center (DRTC) at Vanderbilt University Medical Center conducted a multi-site study that demonstrated that, when controlled and standardized, quantitative magnetic resonance imaging (MRI) of the pancreas is highly reproducible when using different MRI hardware and software in different geographic locations.

This discovery opens a new approach to integrate MRI in multi-site clinical trials related to diabetes and other diseases affecting the pancreas. Adding the use of MRI following a strict protocol to the investigative toolkit for large multisite studies is expected to result in improved diagnosis and treatment of diseases affecting the pancreas, as well as ‘better monitoring and understanding of disease progression.

The Multicenter Assessment Study of the Pancreas in Type 1 Diabetes (MAP-T1D), coordinated at VUMC, is the collaborative product of an international research team using MRI to study the pancreas in people with diabetes type 1. The results are published in the open access journal PLOS ONE.

“MRI is invaluable in diagnosing and monitoring many pancreatic disorders, including chronic and acute pancreatitis, non-alcoholic fatty liver disease, and pancreatic cancer,” said Daniel Moore, VUMC site researcher, PhD, MD, assistant professor of pediatrics and pathology, microbiology and immunology. “Additionally, in recent studies, MRI has been used to better understand the progression of type 1 and type 2 diabetes, as evidenced by changes in the size of the pancreas.

“We know that MRI can have important applications in future diabetes research and ultimately in the clinical management of the disease. Our development, testing and sharing of a standardized pancreatic imaging protocol for MRI is therefore an essential step in advancing this field. “

A key limitation in using MRI to study the pancreas has been the inability to perform precise, multi-site studies of the pancreas using MRI imaging due to the high variability of images produced by different MRI hardware and software. Additionally, while MRI imaging of the brain and solid tumors has benefited from multisite standardization, the pancreas is difficult to image due to its deep location in the abdomen, its irregular edges, and the potential for artifacts or features that appear in imagery that are not actually present in the body.

For the study, a “phantom”, a carefully calibrated object that is scanned to assess the performance of an imaging device, was imaged at five clinical sites using different MRI hardware and software in order to develop a standardized MRI protocol.

Then, five healthy volunteers underwent MRI imaging at four of the study sites – Austin, Texas; Chicago; Denver; and Nashville, Tennessee – where different MRI equipment was used according to protocol. Measurements were taken for the size, shape of the pancreas, and other specific quantitative factors typically used for diagnosis and disease progression.

John Virostko, MAP-T1D researcher and assistant professor of diagnostic medicine at Dell Medical School at the University of Texas at Austin, designed the phantoms and coordinated the processing and analysis of the MRI images. Virostko was previously at Vanderbilt University Institute of Imaging Science where he initiated pancreatic MRI studies in type 1 diabetes and began this collaboration with Moore.

The use of standardized image processing made it possible to obtain reproducible measurements with coefficients of variation of less than 10%. There was no statistically significant difference to any extent between MRI scanners or between any pair of scanners.

“We were able to show that by using a standardized MRI image acquisition and processing protocol, quantitative MRI of the pancreas performed at multiple locations can be reproduced very accurately,” said Virostko. “For this reason, scientists around the world can follow this same protocol to incorporate MRI into multisite clinical trials comparing pancreatic imaging measurements and metabolic status in people with type 1 or type diabetes. 2, “he said.

“This has positive implications for scientists studying other diseases affecting the pancreas, and we share this protocol universally to support future research,” Moore said. “We hope that scientists applying imaging to the pancreas will adopt a standardized protocol that will ultimately allow everyone to combine data from various studies and thus accelerate progress.”

Adopting a standardized protocol will also allow the application of radiomics, a high throughput quantitative approach to imaging. Shifting to an objective approach will support the application of new advanced analytical methods and allow more precise analysis of these data without relying primarily on visual inspection of MRI scans of the pancreas, as has been the case for most. clinical data to date, said Virostko. .

VUMC is a clinical center for Type 1 Diabetes TrialNet, an international network of academic institutions, endocrinologists, physicians, scientists and healthcare teams at the forefront of type 1 diabetes research. Through TrialNet, individuals are screened for specific autoantibodies or proteins produced by the immune system associated with type 1 diabetes. It is now known that people with two or more autoantibodies have type 1 diabetes. 1, but it is not known when they might progress to persistently high blood sugar and new symptomatic disease (stage 3).

The research team then plans to investigate whether the size of the pancreas, documented by following the MRI protocol, plays a role in the rate of progression of type 1 diabetes. Since each clinical site has relatively few people. In the early stages of type 1 diabetes, using the standardized MRI approach will help the team integrate data from around the world.

Source:

Vanderbilt University Medical Center

Journal reference:

Virostko, J., et al. (2021) Development of a standardized MRI protocol for the evaluation of the pancreas in humans. PLOS ONE. doi.org/10.1371/journal.pone.0256029.

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About Hector Hedgepeth

Hector Hedgepeth

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