Solving complexity in early clinical imaging
Case study
Overview
It is estimated that approximately 30% of MRI procedures utilise contrast agents, most commonly gadolinium‑based (Gd) compounds. Over the past decade, growing evidence of gadolinium retention in the brain raised safety concerns, prompting regulatory action. Both the FDA and EMA suspended marketing authorisations for several Gd‑based agents and issued guidance to minimise their use. This regulatory shift created a clear medical need to identify and evaluate new contrast agents that could offer comparable imaging performance with improved safety profiles.
In response, a large pharma sponsor developed a novel manganese‑based contrast agent for brain MRI. To support its clinical development, a phase 1b study was designed to compare imaging performance against a Gd‑based comparator while also assessing safety and tolerability in healthy participants.
Challenge
The phase 1b study enrolled 60 healthy participants in a complex four‑treatment, four‑period Williams cross‑over design, with participants randomised into one of four treatment sequences. Each treatment period required an MRI scan conducted seven days apart, resulting in a total of 240 brain MRI scans within a tightly controlled timeline.
The key challenge was to deliver this high‑volume, imaging‑intensive study using a single clinical site—without compromising data quality, operational efficiency, or participant safety.
Solution
ICON leveraged its long‑standing collaboration with the Medical Imaging Center (MIC) at the University Medical Center Groningen (UMCG) to design an integrated single‑site solution.
This approach combined:
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Dedicated use of two 3T MRI scanners
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Allocated MRI timeslots at predefined points including weekdays and weekends, to accommodate each treatment cohort across all four MRI acquisition timepoints
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Clearly defined operational roles, with ICON administering the investigational contrast agent at the UMCG Radiology Department, and UMCG MIC staff conducting all MRI scan acquisitions
Trial participants were housed onsite at ICON’s clinical research unit and transported on foot to the nearby imaging facility, ensuring smooth logistics and participant comfort throughout the study.
Outcome
This trial represents the highest number of MRI acquisitions conducted within ICON Early Clinical using a single‑site model, completed successfully within five months.
Key outcomes for the sponsor included:
- Standardised imaging procedures, reducing variability and minimising the risk of protocol deviations
- Scanner consistency, with each participant scanned on the same MRI system across all treatment periods to preserve data integrity
- Rapid and reliable data transfer, enabling timely cohort‑level analysis
- High‑quality results delivered at unprecedented speed, supporting the sponsor’s accelerated development timelines for this priority compound
ICON delivered an innovative single‑site solution that eliminated the cost, complexity, and operational variability typically associated with multi‑site activation. The co‑location of clinical and imaging facilities enabled a seamless, participant‑centric experience, while ICON’s long‑standing partnership with UMCG, which is rare in imaging‑intensive early phase trials, ensured efficient execution, high data consistency, and accelerated delivery of high‑quality results.