Three-Year International Phase II Trial in Chronic Iron Overload

Challenge

A three-year international Phase II trial evaluated a new therapy for chronic iron overload using MRI measurement of liver and myocardial iron. T2* relaxometry is quantitative but vendor- and sequence-dependent, and the participating sites spanned Asia, Europe, North America and the Middle East with a wide range of scanner platforms and relaxometry experience.

The sponsor needed liver iron concentration and myocardial T2* measured consistently enough to detect treatment-related change over three years, with calibration across platforms, stable analysis conventions and a quality process that kept sites compliant with a demanding protocol.

Intrinsic Imaging’s Solution

Intrinsic Imaging developed image acquisition guidelines for multi-echo gradient echo T2* sequences on each vendor platform, qualified every site with phantom and volunteer acquisitions, and trained site technologists on breath-hold technique, echo spacing and slice positioning for the liver and interventricular septum.

Radiologists with experience in iron quantification analyzed liver and myocardial T2* under a reading charter fixing region-of-interest placement, curve-fitting method and the conversion to liver iron concentration. Each patient was followed by the same analyst where possible, with a second analyst on a prespecified sample for reproducibility.

Images were processed and quality-controlled centrally, with sequence parameter deviations identified at receipt and returned to sites for correction within protocol windows.

Intrinsic Imaging’s Results

• T2* relaxometry standardized across 26 sites on four continents with vendor-specific sequence guidance and phantom qualification
• Approximately 900 liver and cardiac examinations quantified over three years under fixed analysis conventions
• Analyst reproducibility of liver iron concentration within 5% documented on a double-analysis sample
• Sequence parameter deviations caught at central quality control and corrected, with fewer than 3% of visits unevaluable