Purpose: To evaluate and compare the reproducibility of the preferred phenomenological parameter IAUC 60 (initial area under the time-concentration curve [IAUC] defined over the first 60 seconds postenhancement) with the preferred modeling parameter (K trans ), as derived using two simple models, in abdominal and cerebral data collected in typical Phase I clinical trial conditions.
Materials and Methods:Dynamic contrast enhanced MRI (DCE-MRI) time series were acquired at two imaging centers from a group of patients with abdominal tumors and a group with gliomas. At both imaging centers, precontrast T 1 was calculated using a variable flip angle three-dimensional spoiled gradient echo acquisition that was used to quantify tissue contrast agent concentration, allowing voxelwise definition of summary DCE-MRI parameters.Results: A comparison of reproducibility showed that there was no statistically significant difference in reproducibility between IAUC 60 and K trans , although there was a trend towards better reproducibility for K trans (P ϭ 0.0782). The 95% confidence intervals (CIs) for individual changes showed that for IAUC 60 and K trans , changes in excess of 47% and 31%, respectively, are outside the range of normal variability.
Conclusion:Although modeling is more complex and more computationally intensive than an IAUC parameterization, our data suggest this approach to be preferable to a modelfree approach since it provides greater physiological insight without a reduction in statistical power for Phase I/II clinical drug trials.