The first subject scan took place at Aarhus University Hospital in Denmark, using 15 O-water produced, dosed and injected through MedTrace’s P3 automated delivery system. The clinical trial aims to evaluate the use of 15 O-water in PET scans to diagnose coronary artery disease. The trial kickoff, announced on May 20, comes about two months after MedTrace received FDA approval of the company’s Investigational New Drug (IND) application and the approval to commence the trial.
Oxygen-15 labeled water has a reputation as a gold-standard radioactive tracer for PET imaging, but supply chain problems around the substance have hindered adoption. Hørsholm, Denmark–based MedTrace, which is holding a grand opening in August for new U.S. offices in the IDS Center in downtown Minneapolis, seeks to solve the problem by moving 15 O-water production inside hospitals with an automated point-of-care chemistry system.
“The practical real-time production of 15 O-water with MedTrace’s novel technology promises to revolutionize the practice of cardiac PET imaging by improving patient access to the most accurate approach to the non-invasive diagnosis of coronary artery disease,” said Dr. Marcelo Di Carli, the clinical trial’s principal investigator and professor of radiology and medicine at Brigham and Women’s Hospital and Harvard Medical School.
MedTrace CEO Martin Stenfeldt said the company is moving forward at an incredible pace, with the company’s clinical department growing significantly by year’s end. The company is presently exploring clinical applications not only in cardiology but also in oncology and neurology.