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RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)
Sponsor: MedTrace Pharma A/S
Summary
This a Phase 3, prospective, open-label, multicenter study of \[15-O\]-H2O 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 10 study sites in the United States and Europe. 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 \[15-O\]-H2O 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 hrs after completion of the \[15-O\]-H2O scan.
Official title: A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered [15-O]-H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging (RAPID-WATER-FLOW)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
215
Start Date
2022-05-08
Completion Date
2026-12-31
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
[O-15]-Water PET Myocardial Perfusion Imaging (MPI)
\[15-O\]-H2O injection is a novel PET imaging agent labeled with the radioisotope \[15-O\] administered as an intravenous (IV) injection. Participants will receive \[15-O\]-H2O treatment twice as a part of a single day imaging session. All participants will receive two IV boluses of \[15-O\]-H2O injection in a peripheral vein; one at rest and one during pharmacological stress.
Locations (14)
University of Iowa
Iowa City, Iowa, United States
BAMF Healthcare
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Aarhus University Hospital
Aarhus, Denmark
University Hospital Freiburg, Clinic for Nuclear Medicine
Freiburg im Breisgau, Germany
Department of Cardiology and Angiology -- Hannover Medical School (MHH)
Hanover, Germany
Amsterdam University Medical Center, Department of Radiology and Nuclear Medicine
Amsterdam, North Holland, Netherlands
Sahlgrenska University Hospital
Gothenburg, Sweden
Norrland University Hospital Heart Center
Umeå, Sweden