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)

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.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  [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)