Ferrotran will be tested at ten highly regarded hospitals in three countries: Germany, Switzerland and the Netherlands.
Ferrotran (Ferumoxtran-10) is an ultra-small superparamagnetic iron-based contrast agent (USPIO). It consists of iron oxide nanoparticles stabilized with low molecular weight dextran and sodium citrate. The product has shown to deliver excellent imaging results in the MRI detection of extremely small lymph node metastases.
Ferrotran is thought to be taken up by the mononuclear phagocytic system, particularly in lymph nodes, with less uptake by metastases. In non-metastatic lymph nodes, the presence of Ferrotran is expected to result in lower signal intensity, i.e. lymph nodes appear darkened on T2 and T2*-weighted sequences in the MRI scan compared with native MRI scans. This effect is known as magnetic susceptibility. Metastatic lesions within lymph nodes, however, maintain their signal intensity.
Development of Radboud University Medical Center
Ferrotran is originally a development of Radboud University Medical Center (Radboudumc) in Nijmegen, the Netherlands. It originated in Radboudumc’s quest of new MRI techniques to better map prostate cancer and possible metastases. On the MRI scans one could see cancer metastases as soon as they had a size of approximately 8 millimeters. This proved difficult in practice because the metastases were already so large that treatment was often problematic. This improved considerably when Radboudumc tested Ferrotran as a contrast agent. Metastases were visible with Ferrotran at a size of 2 millimeters, so that the treatment of the cancer could take place much earlier and better. Since then, the contrast agent Ferrotran has been used successfully at Radboudumc in hundreds of cancer patients. Meanwhile, the product is so far developed that it can be tested in clinical trials.
Diagnostic accuracy of Ferrotran-enhanced MRI
Ferrotran will be tested at ten highly regarded hospitals in three countries: Germany, Switzerland and the Netherlands. Up to 180 adult male patients with newly-confirmed metastasized prostate cancer scheduled for resection will participate in the study. It will be an open-label, single-arm, reader-blinded phase 3 study to assess the diagnostic accuracy of Ferrotran-enhanced MRI and unenhanced MRI of pelvic lymph nodes in newly-diagnosed patients with prostate cancer using histopathology as the established reference method. With the clinical trials SPL Medical wants to prove unequivocally that Ferrotran can be used safely and can detect metastases better than other MRI contrast agents.