Imacor AB provides core laboratory services related to image analysis including cardiac magnetic resonance (CMR) images as well as myocardial perfusion SPECT (MPS) images. The Imacor team is certified in GCP (ICH) and operates according to these standards.
The core laboratory services include assisting in study design, staff training, electronic data transfer, rapid quality assurance on a patient per patient basis, usually within hours of data submission.
The image analysis methods utilized by Imacor are scientifically validated by the team members 1-7 and specified in standard operating procedures and include assessment of myocardial function, viability, myocardium at risk, myocardial salvage and myocardial salvage index by CMR as well as perfusion and viability assessment by MPS.
Imacor AB employees are all PhDs with experience of both experimental and clinical research, mainly related to ischemic heart disease. With a focus on the pathophysiological mechanisms underlying acute and chronic ischemic heart disease in combination with experience with cardiac imaging, Imacor offers assistance in developing appropriate study protocols well suited for the endpoints of interest.
Imacor AB can assist in power calculations in preparation for clinical trials based on knowledge of accuracy and precision for the different imaging variables in relation to biochemical markers 13. Imacor AB can also perform statistical analyses of results from a study in preparation for the final study report.
Imacor AB can take the responsibility to develop study specific imaging manual of operations to be distributed among the clinical centres involved in a trial after establishing contact with the persons responsible for imaging at each site. Training by email, phone, webinar and site visits (if necessary) can be handled by Imacor. Training of sites always include submission and quality assessment of qualification patients, preferably two from each site to ensure good quality trial data with minimal data loss as the trial is executed.
Imacor performs image analysis using an in-house developed, FDA 510(k) approved software called Segment 8. The analysis methods are both in vivo and ex vivo validated 1-7, 9-14 for assessment of left ventricular (LV) end-diastolic and end-systolic volumes, LV mass, LV ejection fraction, regional LV function, aortic and pulmonary blood flow, quantitative myocardial perfusion, myocardium at risk, infarct size, myocardial salvage index.
The analysis procedures are standardized and described in standard operating procedures. The quantitative assessment and the subsequent analysis of the imaging data is performed by either Professor Håkan Arheden, Associate Professor Marcus Carlsson or Associate Professor Henrik Engblom, all senior researchers in the Lund cardiac MR group, Lund University, Lund, Sweden.
Imacor offers a unique image data transfer solution called Segment Transfer. Segment transfer is a secure web-based imaging transfer protocol which is easy to use at site and enables quick feedback, usually within hours, to the site and to the study steering committee for each patient. Furthermore, it enables the study monitors to follow the status of patient inclusion online in real time. Consecutive image data will be transferred to Imacor for quality control.
Imacor distributes the Segment Transfer software and is responsible for the education of each site and the study monitors of how to operate the software.