SAN FRANCISCO – Perspectum announced recruitment of the first patient in a multi-center collaborative study to characterize Primary Sclerosing Cholangitis in children, “Prospective Observational Study of Primary Sclerosing Cholangitis (PSC) in Children.” This 10-year collaborative study includes 12 geographically-diverse children’s hospitals in the United States and one Canadian children’s hospital.
Perspectum, through a Clinical Trial Agreement with the National Institute of Health’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Childhood Liver Diseases Research Network (ChiLDReN), will support the seminal study’s 13 pediatric hospitals’ researchers as they seek to understand how liver and biliary disease in children are impacted by interrelated diseases such as, inflammatory bowel disease (IBD), ulcerative colitis, autoimmune hepatitis (AIH) and bacterial cholangitis. This first of its kind study involves pediatric liver and IBD specialists as well as new non-invasive imaging techniques such as Perspectum’s quantitative MRI technologies to characterize the health of liver tissue and biliary tree.
Perspectum’s quantitative imaging tool, MRCP+, that uses computational techniques to enhance conventional magnetic resonance cholangiopancreatography (MRCP) images, will provide biliary tree measurements to evaluate biliary injury and monitor disease progression. Additionally, Perspectum’s non-invasive quantitative MRI-based LiverMultiScan product will provide validated metrics of liver fibro-inflammation and fat. These measurements will be acquired at baseline – as well as after one and five years – in 330 pediatric patients with PSC, aged between 8 and 25. Comparing these results to those from other imaging modalities will enable the study partners to determine which biomarkers of fibrosis and biliary injury can best predict disease progression and guide patient management.
Prof. Alexander Miethke, MD, Cincinnati Children’s Hospital Medical Center, the lead investigator on this study, commented, “We are excited to begin this important study and partnership with Perspectum to better understand the natural history of liver and bile duct changes in children with PSC. We look forward to learning how quantitative MRI-based measurements of liver health can be used to diagnose and follow patients with PSC and exploring how these measurements might be used to predict meaningful outcomes and serve as endpoints for future studies of novel medical therapies.”
Perspectum’s CEO Dr Rajarshi Banerjee said, “We are thrilled to play our role in this critical long-term PSC study. My hope is that Perspectum’s safer precision diagnostics tools will support the establishment of a new care paradigm for children with PSC.”
About PSC and the study
PSC is a rare liver disease in which the immune system attacks the bile ducts, narrowing them and causing strictures, leading to chronic cholestasis. Although it is rare, a significant proportion of patients develop cirrhosis, end stage liver disease requiring liver transplantation, , and/or colorectal cancer. Studies report 15 cases of PSC per million children in North America and over 80% of them also have IBD, which is most commonly ulcerative colitis (UC). When IBD occurs with PSC in children, it has a relatively mild clinical course, but the risk of developing colorectal cancer is 3 or 4 time more likely than IBD without associated liver disease. This new study aims to improve understanding of the risk factors associated with a more rapid progression of PSC, its relationship with co-existent IBD and its impact on the global functioning of children.
Perspectum, a global medical technology company with offices in the U.K., the U.S., Portugal and Singapore, delivers leading digital technologies that help clinicians provide better care for patients with chronic metabolic diseases, multi-organ pathologies and cancer. With a strong focus on precision medicine using advanced imaging and genetics, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers and technologists, Perspectum offers a way to manage complex health problems at scale.
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NIDDK research creates knowledge about and treatments for diseases that are among the most chronic, costly, and consequential for patients, their families, and the Nation. See niddk.nih.gov, Twitter.
About Childhood Liver Disease Research Network (ChiLDReN)
The Childhood Liver Disease Research Network (ChiLDReN) is a collaborative team of doctors, scientists, nurses, research coordinators, medical facilities, patient support organizations and the National Institutes of Health. The ChiLDReN Network has clinical sites and research laboratories in the U.S., Canada, and the United Kingdom. These sites are working together to improve the lives of children and families dealing with rare cholestatic liver diseases. See childrennetwork.org.
VP Corporate Affairs