An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)

Summary

This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.

Timeline

Start

2018-06-05

Primary completion

2022-05-05

Completion

2022-05-05

Outcome

Met primary endpoint

paper Flurpiridaz PET met the efficacy endpoints of the study; PMID 37821170 ↗

paper its sensitivity and specificity were significantly higher than the prespecified threshold value by 2 of the 3 readers. PMID 37821170 ↗

release “Phase III clinical trial of [18F]flurpiridaz PET diagnostic radiopharmaceutical meets co-primary endpoints for detecting Coronary Artery Disease (CAD)” gehealthcare.com ↗

Publications

• Patel KK, Maddahi J, Agostini D, Bax JJ, Beanlands RSB, Berman D, Dorbala S, Heller GV, Knuuti JM, Pelletier-Galarneau M, Tamaki N, Thompson D, Somer EJ, Udelson JE, Bateman TM. Improved assessment of coronary artery disease in obese Patients with flurpiridaz-18F positron emission tomography myocardial perfusion imaging: A prespecified subgroup analysis of the AURORA phase 3 study. J Nucl Cardiol. 2026 May 12:102741. doi: 10.1016/j.nuclcard.2026.102741. Online ahead of print.
• Maddahi J, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Dorbala S, Garcia EV, Feldman J, Heller GV, Knuuti JM, Martinez-Clark P, Pelletier-Galarneau M, Shepple B, Tamaki N, Tranquart F, Udelson JE. Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease. J Am Coll Cardiol. 2023 Oct 17;82(16):1598-1610. doi: 10.1016/j.jacc.2023.08.016.
• Bourque JM, Hanson CA, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Garcia EV, Heller GV, Knuuti J, Tamaki N, Udelson JE, Maddahi J. 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. J Nucl Cardiol. 2021 Jun;28(3):1105-1116. doi: 10.1007/s12350-021-02527-8. Epub 2021 Jan 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Flurpiridaz	Diagnostic / imaging agent	520 mbq	Intravenous
Background	Adenosine	Small molecule	—	Intravenous
Background	Dipyridamole	Other / unclassified	—	Intravenous
Background	Regadenoson	Diagnostic / imaging agent	—	Intravenous

Indications