EIBIR currently provides its support to two industry-funded multi-centre clinical studies:
- The MIPA study, led by the University of Milan and funded by Bayer, is investigating pre-operative breast MRI for breast cancer and recently finished its patient enrolment.
- The SPECIFIC study is investigating myocardial perfusion imaging using perfusion CT and is funded by Siemens and Bayer, with Erasmus Medical Center and University Hospital Tübingen serving as the scientific leads.
The MIPA Study
Multicenter International Prospective Meta-Analysis of Individual Woman Data
The MIPA study is led by EIBIR and Prof. Francesco Sardanelli (University of Milan, Italy). The study conducts a systematic evaluation of pre- operative breast MRI, examining individual patient data in a multi-centre setting with the aim of clarifying matters regarding the ongoing uncertainty in the application of pre-operative MRI in breast cancer patients.
MIPA collects data on recent first-time breast cancer diagnoses and compares surgical outcomes for those who undergo pre-operative MRI with those who do not. Patient recruitment for the study was completed in 2018 with follow-up data continuing to be collected from 34 centres in Europe and beyond. The results will be vital for a better understanding of the effect pre-operative breast MRI has on clinical decision-making. In 2018, MIPA completed its recruitment of the target sample size of 7,000 patients and has since continued with the follow-up and data analysis. Among others, preliminary findings indicate that, pre-operative MRI does not lead to a significant increase in mastectomies thereby providing notable statistical insights informing the current debate.
Within MIPA, EIBIR acts as the contracting partner for all participating centres, provides management and administrative support, and handles all finances and leading dissemination efforts. The study receives funding from Bayer Healthcare, and is endorsed by the European Society of Breast Imaging (EUSOBI).
The SPECIFIC Study
Dynamic Stress Perfusion CT for Detection of Inducible Myocardial Ischemia
The SPECIFIC study is an international clinical study investigating myocardial perfusion imaging, which is funded by Siemens and Bayer with Erasmus University Medical Center (Rotterdam, the Netherlands) as the study sponsor, and the University Hospital Tübingen as co-sponsor.
Cardiac CT provides accurate assessment of the coronary arteries and detects significant coronary stenosis with high diagnostic accuracy. This information is highly relevant, but ignores the haemodynamic relevance of lesions detected this way, which is essential for clinical decision-making. The recent development of third-generation, dual-source CT allows for the assessment of myocardial perfusion, and may determine the haemodynamic relevance of coronary lesions.
The objective of the SPECIFIC study is to determine the diagnostic accuracy of CT myocardial perfusion imaging for the detection of haemodynamically relevant coronary stenosis, as determined by invasive fractional flow reserve as a reference standard in patients with suspected or known coronary artery disease who have been clinically referred for invasive angiography.
SPECIFIC is investigating the feasibility of this approach through an international multi-centre study with recruitment in the Netherlands, Germany, Poland, Switzerland, Japan and the United States. In 2019, the recruitment target of more than 130 patients was reached. Currently, the data is being analysed and first results are expected in Q2-Q3 2020.
Within SPECIFIC, EIBIR provides management and administrative support, handles financial matters between the study and participating sites, as well as dissemination of the study results through well-established channels such as the European Society for Radiology. Additionally, EIBIR monitors the electronic case report forms for the study.