MedTrace, an innovator in PET diagnostic imaging, announces today that a total of five U.S. trial sites are up and running. Senior Director of Clinical Affairs, Emily Vandenbroucke, describes this development as a great boost to the momentum and excitement surrounding the company’s Phase III Clinical Trial.
Washington University in St. Louis, The University of Iowa, University of Pittsburgh Medical Center (UPMC), and University of Texas Southwestern Medical Center (UTSW) in the U.S. are now 15O-water-ready and recruiting in MedTrace’s ongoing Phase III study. They complement previously activated sites Mayo Clinic and Aarhus University Hospital (AUH).
The four new university hospitals have successfully installed and qualified MedTrace’s automated manufacturing system, P3 MT-100, that automates the manufacturing and provides measured doses of 15O-water ready for injection to patients during PET exams. The system plays a central part in MedTrace’s 15O-water Phase III Clinical Trial, RAPID-WATER-FLOW.
With the four new trial sites active, MedTrace now has six active trial sites across Denmark and the U.S. A total of approximately 12 sites are anticipated to participate in the trial across Europe, the U.S., and Canada.
“Multiple sites are essential in securing robustness, diversity, and reliability in any clinical trial. I’m proud that so many different sites are eager to have access to our technology and participate in our 15O-water trial. It’s a tremendous achievement, and speaks to the dedication of all involved, to have a Phase III trial successfully running at some of the top centers in Europe and North America,” says Emily Vandenbroucke, Senior Director of Clinical Affairs at MedTrace.
The Phase III Clinical Trial seeks to evaluate the diagnostic accuracy and safety of 15O-water as a myocardial perfusion PET imaging agent.
For detailed information on the clinical trial, visit: Radiolabeled Perfusion to Identify Coronary Artery Disease Using Water To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)
About the RAPID-WATER-FLOW Trial
The trial is a Phase III, prospective, open-label, multicenter study of 15O-water injection for PET imaging of subjects with suspected CAD. Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study at approximately 12 study sites. Approximately 215 participants will be enrolled to account for an estimated 15% drop-out rate. Screening assessments will occur prior to enrollment to confirm eligibility. All participants will receive two doses of 15O-water as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine). A safety follow-up phone call will occur 24 ± 8 hours after completion of the 15O-water scan.
Forward–looking statement
This news release by MedTrace Pharma A/S (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. The company offers no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Contact:
Emily Vandenbroucke
Senior Director, Clinical Affairs
emily@medtrace.dk
+1 312 805 0489
