SPL Medical achieves important milestone for Ferrotran contrast medium
SPL Medical enrolled the first patient at Charité Hospital in an international registration study into the effectiveness of the contrast fluid Ferrotran for detecting lymph node metastases in prostate cancer patients. The study, which takes place in ten hospitals in Europe, is intended to demonstrate the diagnostic power of the product. SPL Medical, a spin-off from Radboud university medical center, is located on the Novio Tech Campus in Nijmegen.
The first patient was recently included in the multicentre study that SPL Medical is conducting to map the effects of the contrast fluid Ferrotran. The patient, enrolled at the Charité Hospital in Berlin, is the first of 180 patients who will eventually participate in the Phase III study. “This study is a prerequisite for the official approval and clinical registration of Ferrotran,” says Harrie van Baars, Chief Business Officer of SPL Medical. “Although the drug has already been investigated in many studies – with good results – this study is a necessary step for the market introduction and the provision for patients. The first patient in this study is therefore an important milestone for our company. ”
Nano iron particles
The contrast fluid Ferrotran makes very small metastases in the lymph nodes clearly visible on the MRI. Even mini-metastases of up to two millimeters can be visualized with it. It consists of nano-iron particles, which make normal lymph nodes “black” on an MRI, while abnormal glands turn white. This makes them very easy to distinguish from one another, allowing treatment at an early stage, with potentially fewer side effects and more chance of a cure. Other diagnostic techniques do not visualize such small metastases.
In this phase III study, the contrast agent is used in patients with prostate cancer, in whom the prostate and surrounding lymph nodes are surgically removed. Van Baars: “The patients receive an MRI without Ferrotran some time before the surgery, an MRI with Ferrotran just before the surgery, followed by an MRI eight weeks after the surgery. Although Ferrotran is safe and consists only of iron and dextran, potential side effects are also included in this study. The study is being conducted to determine whether Ferrotran can actually detect the affected lymph nodes better than a method without Ferrotran. This is done by first performing a normal MRI on the patient, and then an MRI with Ferrotran.