High-volume medical imaging to support a MASH clinical trial

The sponsor contracted ICON Medical Imaging to support a clinical trial that eventually resulted in the first MASH drug approval from the FDA. This pivotal phase 3 randomised, double-blind study to improve MASH and reduce progression to cirrhosis and/or hepatic decompensation was high-volume, with more than 9,753 scans across two imaging modalities. A closely coordinated effort between the sponsor, ICON experts and the Duke University laboratory ensured clear communication around imaging data and analysis to support expedited processes and deliver this historic therapy

ICON Medical Imaging supported the medical imaging portion of the trial, collecting more than 6,000 MRI scans and over 3,000 DXA scans from 263 sites in 15 countries. The team had to ensure rapid quality control and delivery of scans to the Duke University laboratory daily, as the sponsor had contracted their experts for image analysis. This required constant communication to maintain data integrity and flow. In addition to the sheer volume of images and the complexity of delivering and receiving data through external systems, Duke and ICON committed to expedited timelines for the sponsor, completing screening in a 3–5-day window.

ICON brought a wealth of knowledge and experience to optimise this complex process, having conducted 118 MASH studies across 32,000+ patients and healthy volunteers. We dedicated 14 medical imaging specialist experts in MRI and DXA modalities to ensure timely quality control assessments of all images collected from sites before they were delivered to the Duke University laboratory. To ensure transparent communication and prevent delays, we maintained daily communication between internal teams, with weekly check-ins with the sponsor operational team and bi-weekly meetings with sponsor and ICON cross-functional teams. A unique, intricate workflow was established to optimise efficiency in moving data back and forth from ICON and Duke, with ICON data analyst teams assisting in transfers through a shared system and uploading results to our PIER system to leverage automatic site result notifications.

Our commitment to collaborative, efficient and transparent communication enabled the expedited reads and high-quality data. The unique workflow and strong relationship developed between stakeholders contributed to the overall success of this study in achieving expedited timelines and was reflected in consistently high ENGAGE survey scores across all categories and our rank as first Partner of Choice. The high-quality data and results included 99% on-time data delivery to support data cuts and database locks during critical internal and regulatory audits leading to regulatory approval.

Our agile, unique solutions accommodated large volumes of data flow and produced high-quality deliverables that contributed to the first MASH drug approval from the FDA. ICON Medical Imaging is now contracted on the sponsor’s three other phase 3 MASH trials.