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RECRUITING
NCT05134012
PHASE3

RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)

Sponsor: MedTrace Pharma A/S

View on ClinicalTrials.gov

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

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)

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