Five-Year International Phase II Iron Overload Trial With 4,500 MRI Scans

Challenge

A large five-year international Phase II trial of a new therapy for chronic iron overload in transfusion-dependent and hereditary populations involved more than 4,500 MRI examinations for liver and cardiac iron quantification. Over five years, scanner upgrades, software changes and staff turnover at sites threaten the stability of quantitative T2* measurement, and drift of even a few percent would be comparable to the treatment effect being measured.

The sponsor needed a core lab able to hold acquisition and analysis constant across a long duration, manage a large and continuous read volume, and provide expert radiologist consultation on protocol questions as the trial evolved.

Intrinsic Imaging’s Solution

Intrinsic Imaging provided expert radiologist consultation during protocol and charter development, specifying multi-echo T2* acquisition for liver and heart on each vendor platform and establishing a phantom-based qualification and requalification program to detect scanner changes over the trial's duration.

Gastrointestinal and cardiovascular radiologists experienced in liver and cardiac MRI analyzed T2* under a fixed reading charter, with longitudinal analyst assignment, a standing reproducibility sample and periodic recalibration. Quality control at receipt verified sequence parameters against the charter on every examination.

Project management tracked more than 4,500 scheduled examinations against protocol windows across five years, requalifying sites after scanner upgrades and maintaining the analysis conventions without change through database lock.

Intrinsic Imaging’s Results

• More than 4,500 liver and cardiac MRI examinations quantified over five years under unchanged analysis conventions
• Phantom-based requalification performed after each of 19 scanner upgrades or software changes at participating sites
• Longitudinal analyst reproducibility maintained within 5% for liver iron concentration across annual reproducibility samples
• Fewer than 3% of scheduled examinations unevaluable across 34 sites in 12 countries