Perspectum delivers cutting-edge digital technologies that help clinicians provide better care for patients with liver disease, diabetes, and cancer.
Primary liver cancer is the fastest growing cause of cancer-related deaths in the USA, with 18,000 men and 9,000 women dying each year. Secondary liver cancer is an additional substantial problem with 50,000 deaths each year. American guidelines for management of liver cancer indicate that for early-stage tumors surgical resection is the best option. After the operation, where the tumor and surrounding tissue is removed, patients stay in hospital with close monitoring for several days. Unfortunately, alongside cancer, many patients have parenchymal liver disease either from cirrhosis (associated with primary liver cancer), fatty liver disease or chemotherapy associated steatohepatitis following neoadjuvant treatment. This often goes undiagnosed prior to surgery and compromised liver health/function can affect recovery from resection and even lead to post-hepatectomy liver failure. As such, consensus opinion among surgeons is converging on agreement that a safe lower limit for the future liver remnant (FLR) should be 20% for a patient with a normal healthy liver, 30% for those with fatty liver and 40% for those with fibrosis/cirrhosis. There is a lack of clear evidence guiding treatment for individuals, often due to the failure to detect parenchymal liver disease or difficulty in interpreting blood tests; biopsy scores are associated with risk of bleeding and poorly accepted by patients. Our technology provides an individualized report from a 10-minute MRI scan detailing the liver volume as well as the level of fat and fibro-inflammation. This can inform surgical planning and allow patients to avoid the risk of poor post-operative outcomes.
Hepatica is a new FDA 510(k) cleared medical device and surgical decision support tool. It receives MRI scans through a secure cloud-based portal before anonymization during the analysis process. Hepatica then uses post processing software to analyze images before sending back a full quantitative analysis of the patient's liver health as a report for the surgical team. Using our proprietary biomarker corrected T1 (Banerjee et al., 2014, Pavlides et al., 2016) we are able to provide quantitative metrics of fibrosis and inflammation which are both common pathology for patients with liver cancer. Hepatica then uses a new deep-learning tool to automatically delineate the whole liver in 3D to accurately measure the volume. Finally, a trained operator places eight anatomical landmarks, and the boundaries are automatically drawn within the liver, identifying what is known as the Couinaud segments. This information is then combined with the liver health score, but crucially, allows an understanding of the liver health within the region that will remain following the planned surgery. This provides a unique insight to surgical teams and the ability to non-invasively assess the full liver prior to surgical resection. Other products provide separate elements, but Hepatica is the first tool to integrate liver health measurement and future liver remnant liver volumetry. Hepatica enables surgeons and radiologists to evaluate the risk of surgery for individual patients based on the health of the FLR and provides them with the confidence to choose the best treatment pathway to improve patient outcomes.
Imaging is a key technique used in the early detection, surveillance, diagnosis, staging and post-treatment follow-up of patients with primary liver cancer. The current guidelines state that for diagnosis, therefore pre-surgical imaging of patients, either an MRI or CT must be performed. MRI has superior soft tissue contrast to CT and contrast enhanced MRI is commonly used as an alternative to CT. Contrast agents are not always well tolerated and they add additional time and cost for imaging so there is a need for better non-contrast, non-invasive imaging techniques. Hepatica combines superior imaging technology with a completely non invasive assessment of liver health. Currently available solutions can provide either volumetry measurements for the liver or metrics of total liver function. However, Hepatica is uniquely positioned to provide a report detailing both liver health specific to segmented areas of the liver and liver volume metrics. Importantly, currently available liver function tests give an indication of the total liver function not that of the future liver remnant. Depending on the heterogeneity of the health of the liver parenchyma this could lead to an overestimation or underestimation of underlying liver disease. Understanding the health of the liver left behind following surgery is crucial for ensuring the correct treatment decisions are made for individual patients and ensuring the best possible patient outcomes following resection surgery.
The accuracy and precision of Hepatica and the validity of the marketing claims was thoroughly examined during a performance testing process, reviewed by the FDA and found at the link: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203280.pdf A detailed description of two contrasting case studies was also published in the British Journal of Radiology (Sethi et al, 2021: https://dx.doi.org/10.1259%2Fbjrcr.20200172). Perspectum published data from a registered clinical trial of 143 patients with liver cancer which demonstrated that patients with an elevated level of fibroinflammation (as measured by Hepatica) stayed in hospital an average of 1.5 days longer. This can be projected to an additional cost of $6000 of in-patient bed costs alone.Published in the journal PLOS One (Mole et al, 2020 (https://doi.org/10.1371/journal.pone.0238568) Customer testimonials for Hepatica below demonstrate the utility and value of Hepatica: “Hepatica is an advanced oncology tool that provides objective information to guide personalized clinical management. It is an excellent application of smart imaging and Artificial Intelligence in medicine, and I look forward to seeing how it can be used in a variety of indications to improve clinical care.” Professor Claude Sirlin MD, Chair of the Liver Imaging Reporting and Data System, American College of Radiologists. “Thanks for the scan. Basically, it’s a game-changer. Because the liver is really not very well, we won’t be able to do the operation in one go, so we need to do a two-stage approach. That’s how valuable and useful this scan is” Professor Myrddin Rees OBE, Consultant Hepatobiliary Surgeon, UK.
Hepatica answers a clinical unmet need for patients with liver cancer. It is a novel technology that brings a unique insight in to the health of the FLR. Using Hepatica prior to surgery allows personalized treatment planning and ensures surgeons can perform more effective resection surgeries, directly improving patient outcomes.