INTRODUCTION: Radio-frequency ablation (RFA) is a promising minimal-invasive 
treatment option for early liver cancer, however monitoring or predicting the 
size of the resulting tissue necrosis during the RFA-procedure is a challenging 
task, potentially resulting in a significant rate of under- or over treatments. 
Currently there is no reliable lesion size prediction method commercially 
available.
OBJECTIVES: ClinicIMPPACT is designed as multicenter-, prospective-, 
non-randomized clinical trial to evaluate the accuracy and efficiency of 
innovative planning and simulation software. 60 patients with early liver cancer 
will be included at four European clinical institutions and treated with the 
same RFA system. The preinterventional imaging datasets will be used for 
computational planning of the RFA treatment. All ablations will be simulated 
simultaneously to the actual RFA procedure, using the software environment 
developed in this project. The primary outcome measure is the comparison of the 
simulated ablation zones with the true lesions shown in follow-up imaging after 
one month, to assess accuracy of the lesion prediction.
DISCUSSION: This unique multicenter clinical trial aims at the clinical 
integration of a dedicated software solution to accurately predict lesion size 
and shape after radiofrequency ablation of liver tumors. Accelerated and 
optimized workflow integration, and real-time intraoperative image processing, 
as well as inclusion of patient specific information, e.g. organ perfusion and 
registration of the real RFA needle position might make the introduced software 
a powerful tool for interventional radiologists to optimize patient outcomes.