The Clinical Research Unit at Oslo University Hospital was selected as the sole centre worldwide to conduct a “first-in-human” study of an entirely new MRI contrast agent. Much of the preclinical development were carried out in Norway by GE HealthCare employees.The research was supported by grants from the Norwegian Research Council.
Hasse Khiabini Zaré, Head of the Clinical Research Unit, described the study as both demanding and exciting:
“The study protocol was strict, with timelines that had to be met almost to the minute. I was available on my mobile 24/7 during the study, which is unusual but necessary in this case,” Zaré said.
The trial, a first-in-human clinical evaluation, investigated the safety of a manganese-based contrast agent that could offer benefits such as reduced risk of tissue deposition and improved safety for certain vulnerable patient populations compared to gadolinium-based agents. The new MRI contrast agent may also provide comparable imaging capabilities and potentially lower environmental impact.
The study was conducted in 2022 at Oslo University Hospital, Rikshospitalet, with the Clinical Research Unit selected by GE HealthCare as the only centre for this research.
“It’s a great honour to be chosen in tough competition with other research institutions. We worked closely with GE HealthCare’s team in London, who were responsible for the study, contributing to the protocol design as well as its implementation,” Zaré added.
Hasse Khiabini Zaré, head of the Clinical Research Unit, talks about the study at the general meeting at Rikshospitalet. Photo: Elisabeth Kirkeng Andersen
Promising Results
The study results were presented at the Contrast Media Research Symposium in Oslo in October 2024. They revealed that the contrast agent under development was well-tolerated by healthy volunteers, with no serious adverse events, dose-limiting toxicities or clinically relevant findings reported.
GE HealthCare sees two main reasons for exploring alternatives to gadolinium in contrast agents: Markedly reducing the potential risk of tissue deposition in patients and offering a more environmentally sustainable option.
Evy Stavik, Global Head of CMC Development, R&D, at GE HealthCare Pharmaceutical Diagnostics (PDx) segment, noted that a significant amount of the preclinical work on the new agent was conducted in Oslo:
“We received funding from the Norwegian Research Council to enable progression of the agent from early preclinical to the first -in human clinical trial, some of which was also performed at Oslo University Hospital. Even for a large global company like ours, such public funding can be pivotal for launching projects internally. It leveraged our expertise here in Oslo and allowed us to build some additional capability,” Stavik explained.
Stavik also mentioned that GE HealthCare has decided to pursue the clinical development of this contrast agent, though no timeline has been shared.
“This is a completely new class of contrast agents that now holds a strategically important position for us,” Stavik added.
Evy Stavik, Global Head of CMC Development, R&D, at GE HealthCare Pharmaceutical Diagnostics (PDx), says that a large part of the preclinical research on the new contrast agent was conducted in Oslo. Photo: Torunn Heyeraas / private.
Sigrid Fossheim is Global Head of MRI and Ultrasound at GE HealthCare PDx. She states:
“GE Healthcare’s MRI portfolio consists of several gadolinium-based contrast agents. We do however have an ambition to offer radiologists a full product portfolio addressing different patient needs. The development of our manganese-based agent is therefore a key element in our global growth strategy”.
Important for GE HealthCare globally
The global leadership at GE HealthCare is also interested in the developments happening in Norway and believes that this is grounded in the long and proud tradition Norway has in the development and production of contrast agents.
Paul Evans, Global Head of R&D at GE HealthCare, highlighted the significance of the agent in a press release:
“This contrast agent represents an important step towards more personalised and sustainable patient care.”
The release also noted:
GE HealthCare operates two facilities for contrast agents in Norway. One is in Oslo, where the manganese-based agent was developed, and which celebrated its 150th anniversary in 2024. The second is in Lindesnes, producing active pharmaceutical ingredients and marked its 50th anniversary.
Kevin O’Neill, President and CEO of GE HealthCare’s Pharmaceutical Diagnostics (PDx) segment, remarked:
“As we celebrate milestone anniversaries for these two sites, the results from this Phase I study remind us of Norway’s legacy of innovation, shaping the field of diagnostic imaging and improving patient outcomes worldwide.”
Inven2 Impressed
Siri Kolle, responsible for clinical trials at Inven2, oversaw the agreement for this study. She expressed admiration for the Clinical Research Unit and GE HealthCare:
“This study exemplifies how international collaboration can provide significant research opportunities for both patients and research environments. Norway, with its strong expertise in radiology and pharmaceutical diagnostics, has proven it can deliver at a high international level,” Kolle stated.
She also highlighted the role of public funding:
“This project illustrates how government support, such as BIA funding from the Norwegian Research Council, can be a key factor in securing international research projects for Norway while building local expertise.”
Siri Kolle, VP Clinical Trials in Inven2. Photo: Moment Studio/ Inven2.
Key Facts
Clinical Research Unit, Oslo University Hospital
– Facilitates patient-focused research by providing facilities, specialised personnel, and equipment for clinical trials.
– Led by Hasse Khiabini Zaré.
– Staff includes nine research nurses, four senior physicians, one pharmacist, and other specialists.
– Manages approximately 25 studies at any given time, focusing on Phase 1 to early Phase 3 trials, often involving challenging studies on biological drugs.
GE HealthCare Globally and in Norway
– Leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator.
– $19.6 billion in revenue and approximately 51,000 employees.
– GE HealthCare has a legacy in Norway for 150 years, from the legacy Nygaards & Co. The PDx segment in Norway (GE Healthcare AS) is now employing about 1,200 people. Additionally comes the segments within Ultrasound and Imaging.
– GE Healthcare AS site in Oslo includes manufacturing plant for pharmaceuticals, as well as research & development, regulatory affairs, pharmacovigilance, sales, service, and customer support.
– Lindesnes factory produces the active pharmaceutical ingredients of MRI and x-ray contrast agents for the global market, with GE HealthCare recently investing NOK 800 million in the facility.
– GE HealthCare is the largest contributor to mainland healthcare exports in Norway, and 2% of mainland exports.