Refereed journal article or data article (A1)

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




List of Authors: Bourque Jemieson M, Hanson Christopher A, Agostini Denis, Bateman Timothy M, Bax Jeroen J, Beanlands Rob SB, Berman Daniel S, Garcia Ernest V, Heller Gary V, Knuuti Juhani, Tamaki Nagara, Udelson James E, Maddahi Jamshid

Publisher: SPRINGER

Publication year: 2021

Journal: Journal of Nuclear Cardiology

Journal name in source: JOURNAL OF NUCLEAR CARDIOLOGY

Journal acronym: J NUCL CARDIOL

Volume number: 28

Number of pages: 12

ISSN: 1071-3581

eISSN: 1532-6551

DOI: http://dx.doi.org/10.1007/s12350-021-02527-8


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/m(2); 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.


Last updated on 2022-03-10 at 15:18