11 February 2020

SPL Medical, based at the Novio Tech Campus in Nijmegen, is starting an international registration study for its contrast agent ferrotran. The study, which aims to demonstrate the diagnostic efficacy of the agent, is being conducted in ten hospitals in Germany, Switzerland and the Netherlands, including Radboudumc.
Mini-metastases in the picture
Ferrotran is a product of the Radboudumc spin-off SPL Medical. The contrast agent makes very small metastases in the lymph nodes highly visible on MRI scans. Even mini-metastases less than two millimeters in diameter can be detected with this approach. The drug consists of nano-iron particles, which make normal lymph nodes on an MRI scan appear black, while abnormal glands appear white. This makes it very easy to distinguish them from each other. Because ferrotran also makes the lymph vessels visible, the mini-metastases can be located with outstanding accuracy. This enables treatment – for example with targeted radiotherapy – at an early stage, resulting in fewer side effects and improving the chance of a cure. Other diagnostic techniques are limited in resolution to four to six millimeters and cannot detect such small metastases.
The first version of the product was developed in the USA in the late 1990s. Jelle Barentsz, professor of Functional Imaging at Radboudumc, discovered the value of this drug in patients with lymph node metastases. "He managed to obtain the rights for the drug for Radboudumc," says Harrie van Baars, Chief Business Officer at SPL Medical. "He then continued developing the product to make very small metastases visible."
According to Barentsz, clinical studies at Radboudumc have included hundreds of patients with various forms of cancer, such as cancer of the rectum, esophagus, pancreas, head-and-neck and prostate. "The results were so encouraging," he says, "that the product was privatized in 2015 with the spin-off SPL Medical."
Clinical trial
Although a great deal of research data on ferrotran has been published in scientific journals, the product has not yet been authorized for the market. This requires a clinical registration study, which is now beginning. Van Baars: “This study is the prelude to the official authorization and market introduction of the product in Europe. We will study the use of ferrotran in 180 patients in ten hospitals in Germany, Switzerland and the Netherlands, including Radboudumc."
Compassionate use
Although the agent has not yet been authorized for the market, it can sometimes be used for approved clinical studies, such as those taking place at Radboudumc. Some hospitals can also use the agent under strict conditions as part of a ‘compassionate use’ program for patients with life-threatening, long-lasting or seriously debilitating illnesses. Van Baars: “In that context, the first patient with metastatic prostate cancer in Switzerland has recently received ferrotran. With the clinical trial and the compassionate use program, our goal of making ferrotran widely available for cancer patients has come much closer to realization.”

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