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31.01.2021 | ORIGINAL ARTICLE

Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging

verfasst von: Jamieson M. Bourque, MD, MHS, Christopher A. Hanson, MD, Denis Agostini, MD, PhD, Timothy M. Bateman, MD, Jeroen J. Bax, MD, PhD, Rob S. B. Beanlands, MD, Daniel S. Berman, MD, Ernest V. Garcia, PhD, Gary V. Heller, MD, Juhani Knuuti, MD, Nagara Tamaki, MD, PhD, James E. Udelson, MD, Jamshid Maddahi, MD

Erschienen in: Journal of Nuclear Cardiology | Ausgabe 3/2021

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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

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Titel: Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging
verfasst von: Jamieson M. Bourque, MD, MHS
Christopher A. Hanson, MD
Denis Agostini, MD, PhD
Timothy M. Bateman, MD
Jeroen J. Bax, MD, PhD
Rob S. B. Beanlands, MD
Daniel S. Berman, MD
Ernest V. Garcia, PhD
Gary V. Heller, MD
Juhani Knuuti, MD
Nagara Tamaki, MD, PhD
James E. Udelson, MD
Jamshid Maddahi, MD
Publikationsdatum: 31.01.2021
Verlag: Springer International Publishing
Erschienen in: Journal of Nuclear Cardiology / Ausgabe 3/2021
Print ISSN: 1071-3581
Elektronische ISSN: 1532-6551
DOI: https://doi.org/10.1007/s12350-021-02527-8

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Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging