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.”
