The global trial, which is expected to run for 12 months, will enrol adults with suspected Coronary Artery Disease (CAD) and seeks to evaluate the use of 15 O-water PET in its diagnosis
MedTrace Pharma scans first patient in RAPID-WATER-FLOW trial. (Credit: Silas Camargo Silão from Pixabay)
Pharma and medical device company MedTrace Pharma announced the start of scanning of participants in its RAPID-WATER-FLOW Phase 3 clinical trial.
The RAPID-WATER-FLOW is a multicenter phase 3 trial of 15O-H2O injection for PET imaging of participants with suspected Coronary Artery Disease (CAD).
The first subject scan was conducted at Aarhus University Hospital in Denmark just two months after the firm got FDA approval for its Investigational New Drug (IND) application and approval to start the trial.
The trial will enrol 182 evaluable subjects with suspected CAD at multiple sites in the US, Denmark, Sweden, and the Netherlands.
Brigham and Women’s Hospital and Harvard Medical School Professor of Radiology and Medicine Marcelo Di Carli said: “I am thrilled by the recruitment of the first subjects into the RAPID-WATER-FLOW study.
“This is a significant milestone for this exciting and important study and the first step towards bringing 15 O-water as a clinical myocardial perfusion agent in the United States.
“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.”
According to the firm, MedTrace’s technology generates and dispenses 15O-water automatically to patients at the point of care,
MedTrace’s automated software solution provides a fully quantitative and visual 15O-water image analysis for blood flow and segmental perfusion data, and aid clinicians to diagnose patients accurately and promptly.
MedTrace Pharma CEO Martin Stenfeldt said: “I am beyond impressed with the dedication from the MedTrace clinical team and from our partners at AUH.
“They made it possible to reach this significant milestone in less than two months after we received the green light from the FDA.
“It shows that our company is moving at an incredible pace which is made possible by the talented and passionate people onboard.”