Q&A: Perspectum to evaluate imaging device as tool to identify NASH patients
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Perspectum announced it will evaluate the use of LiverMultiScan as a diagnostic tool to identify eligible patients for enrollment into nonalcoholic steatohepatitis clinical trials.
The Virginia Commonwealth University, University of Virginia, Mount Sinai, and Liver Centers of Texas will collaborate in conducting the Non-Invasive Quantification of Liver Health in NASH (N-QUAN) trial as part of the evaluation. This prospective trial will include 225 patients with suspected NASH.
Healio Gastroenterology spoke with Andrea Dennis, PhD, head of biomarker sciences at Perspectum, to discuss the trial and the next steps in Perpsectum’s research.
Healio: Why did Perspectum decide to launch this NASH study?
Dennis: LiverMultiScan uses quantitative magnetic resonance imaging to characterize patients’ livers. The device provides measures of liver fat, liver iron and a propriety metric called iron corrected T1 (cT1). With the growing prevalence of [NASH], it is important to find a noninvasive alternative to liver biopsy, to identify patients who are likely to meet the criteria for any drugs that come to the market. Further, monitoring the response to these drugs is essential for effective management. LiverMultiScan offers potential as a diagnostic tool, aid to diagnosis and monitoring tool.
We have entered cT1 into the biomarker qualification program with the FDA to be evaluated as a diagnostic enrichment biomarker to identify patients most likely to meet the histopathological criteria to enter a NASH clinical trial; essentially as a screening tool. The first part of the program involved submitting a letter of intent, which is a brief document showing the clinical and technical validation of the technology and highlighting the available evidence to demonstrate its potential as a biomarker for the specific context of use. The FDA reviewed this evidence and then issued a letter of support for our ongoing investigation and invited us to submit a full qualification plan, which requires a larger, more comprehensive body of evidence. The N-QUAN trial was designed to provide independent validation of our previous observations. Once this study is complete, we will submit the results to FDA as part of our full qualification package.
Healio: Would you please describe the study design?
Dennis: N-QUAN is a prospective, cross-sectional, observational study. We are recruiting patients who are being screened by their clinicians with a liver biopsy, to receive a LiverMultiScan. With these paired data we hope to validate our previous finding that cT1 can identify those at high risk for NASH.
Healio: What do you hope to accomplish with the study?
Dennis: This will be a very rich data set for us. We aim to recruit 225 patients from four sites in the United States. This will not only provide a good sample size on which to perform our analysis but will also provide us with a broad range of data from different demographic groups and MRI scanners. Hopefully this study will validate cT1 as a diagnostic screening biomarker to identify patients with NASH.
Healio: What is the next step?
Dennis: As a biomarker undergoing the qualification program with the FDA, our evidence demonstrating both clinical and technical validation needs to be comprehensive and rich. We already have a good body of evidence, but an opportunity arose to apply directly to FDA for a grant to support ongoing research under the biomarker qualification program. We applied and were fortunate enough to be awarded $250,000 to support our research. With these funds we are performing an additional technical validation study of 60 patients who have already had a biopsy to confirm their NASH status and invite them for a LiverMultiScan. We will then rescan these participants 2 weeks later to assess our scan-rescan variability in this population. This study is called CATE-NASH (characterization and technical evaluation in NASH). Results from this study will give us further confidence in the stability of cT1 over time and will help to inform its utility beyond screening, for example, as a monitoring biomarker. Once completed, the results from both studies will form part of our full qualification package to be submitted to the FDA as our final submission for this biomarker qualification.