Setting up and running multicentre clinical studies is time-consuming and comes with many administrative tasks. The European Institute for Biomedical Imaging Research (EIBIR) provides support services ranging from clinical studies investigating imaging methods to those evaluating imaging methods.

In addition to administrative and management support, EIBIR also provides an electronic data capture platform for data collection, and together with the ESR, EIBIR is also working on a catalogue of existing imaging databases.

EIBIR currently provides such support to two industry-funded multicentre clinical studies:

  • 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, 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.

Both studies have completed subject enrolment and inclusion, and are now nearing completion with initial publications being finalised for journal submissions.

Electronic data capture platform

EIBIR’s Electronic Data Capture (EDC) platform, launched in 2018, can be used to collect and manage almost any type of digital data which is part of a clinical study, including DICOM images. EIBIR provides support in setting up the case report forms and data collection instruments.

Recently, the platform was used by the EUCLID project, a European Commission Tender project on clinical diagnostic reference levels for x-ray medical imaging led by the ESR, and by a large multicentre study on a machine learning CT-derived FFR application under the lead of Erasmus Medical Center.

Catalogue of existing imaging databases

The ESR is collaborating with the Biobanking and Biomolecular Resources Research Infrastructures – European Research Infrastructure Consortium (BBMRI-ERIC) to support the integration of imaging data with biobank databases for the purposes of creating a European biobank for medical imaging.

Over the course of 2019, ESR experts, supported by EIBIR, started work on a catalogue of standardised descriptions of the image collections that will be easily understood by machines and to extend the BBMRI-ERIC directory so it can be used in AI and machine learning research. The technical aspects of the catalogue are currently being finalised.

SPECIFIC

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 multicentre study with recruitment in the Netherlands, Germany, Poland, Switzerland, Japan and the United States. All subjects have already been examined, and the study aims to publish its first results soon.

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 of Radiology. Additionally, EIBIR monitored the electronic case report forms for the study.

MIPA

The MIPA study is led by EIBIR and Prof. Francesco Sardanelli from the University of Milan. The study conducts a systematic evaluation of pre-operative breast MRI, examining individual patient data in a multicentre 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. 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.

EIBIR acts as the contracting partner for all participating centres in the MIPA study, provides management and administrative support, leads dissemination efforts, and handles all finances.

If you would like to learn more about the support to clinical studies EIBIR offers, visit the website at www.eibir.org.