Jamieson M Bourque1,2, Christopher A Hanson3, Denis Agostini4, Timothy M Bateman5, Jeroen J Bax6, Rob S B Beanlands7, Daniel S Berman8, Ernest V Garcia9, Gary V Heller10, Juhani Knuuti11, Nagara Tamaki12, James E Udelson13, Jamshid Maddahi14,15. 1. Division of Cardiovascular Medicine and the Cardiovascular Imaging Center, Department of Medicine, University of Virginia Health System, Box 800158, 1215 Lee Street, Charlottesville, VA, 22908, USA. jbourque@virginia.edu. 2. Department of Radiology, University of Virginia Health System, Charlottesville, VA, USA. jbourque@virginia.edu. 3. Division of Cardiovascular Medicine and the Cardiovascular Imaging Center, Department of Medicine, University of Virginia Health System, Box 800158, 1215 Lee Street, Charlottesville, VA, 22908, USA. 4. Nuclear Medicine Department, Normandy University Hospital, Caen, France. 5. Mid America Heart Institute, Saint Luke's Hospital, Kansas City, MO, USA. 6. Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. 7. Division of Cardiology, University of Ottawa Heart Institute, Ottawa, ON, Canada. 8. Department of Imaging (Division of Nuclear Medicine) Medicine, and Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, CA, USA. 9. Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA. 10. Department of Cardiology, Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ, USA. 11. Turku PET Centre, University of Turku and Turku University Hospital, Turku, Finland. 12. Department of Nuclear Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan. 13. Division of Cardiology, Department of Medicine, Tufts Medical Center, Boston, MA, USA. 14. Division of Nuclear Medicine, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, CA, USA. 15. Division of Cardiology, Department of Medicine, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, CA, USA.
Abstract
BACKGROUND: Positron emission tomography (PET) myocardial perfusion imaging (MPI) with the novel radiopharmaceutical Fluorine-18 Flurpiridaz has been shown in Phase 1, 2, and first Phase 3 clinical studies to be safe and effective in diagnosing coronary artery disease (CAD). We describe the methodology of the second FDA-mandated phase 3 prospective, open-label, international, multi-center trial of F-18 Flurpiridaz PET MPI. METHODS: The primary study end point is to assess the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD [≥ 50% by quantitative invasive coronary angiography (ICA)] in patients with suspected CAD. The secondary endpoints are to evaluate the diagnostic efficacy of F-18 Flurpiridaz PET MPI compared to Tc-99 m-labeled SPECT MPI in the detection of CAD in all patients and in the following subgroups: (1) females; (2) patients with body mass index ≥ 30 kg/m2; and (3) diabetic patients. This trial's design differs from the first phase 3 trial in that (1) comparison to SPECT is now a secondary end point; (2) patients with known CAD are excluded; and (3) both SPECT and PET MPI are performed before ICA. CONCLUSIONS: This second phase 3 study will provide additional evidence on the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD. TRIAL REGISTRATION NUMBER: NCT03354273.
BACKGROUND: Positron emission tomography (PET) myocardial perfusion imaging (MPI) with the novel radiopharmaceutical Fluorine-18 Flurpiridaz has been shown in Phase 1, 2, and first Phase 3 clinical studies to be safe and effective in diagnosing coronary artery disease (CAD). We describe the methodology of the second FDA-mandated phase 3 prospective, open-label, international, multi-center trial of F-18 Flurpiridaz PET MPI. METHODS: The primary study end point is to assess the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD [≥ 50% by quantitative invasive coronary angiography (ICA)] in patients with suspected CAD. The secondary endpoints are to evaluate the diagnostic efficacy of F-18 Flurpiridaz PET MPI compared to Tc-99 m-labeled SPECT MPI in the detection of CAD in all patients and in the following subgroups: (1) females; (2) patients with body mass index ≥ 30 kg/m2; and (3) diabetic patients. This trial's design differs from the first phase 3 trial in that (1) comparison to SPECT is now a secondary end point; (2) patients with known CAD are excluded; and (3) both SPECT and PET MPI are performed before ICA. CONCLUSIONS: This second phase 3 study will provide additional evidence on the diagnostic efficacy of F-18 Flurpiridaz PET MPI in the detection of significant CAD. TRIAL REGISTRATION NUMBER: NCT03354273.
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