The FLARE (Flurpiridaz vs. Rubidium Evaluation) Trial

NCT07761728 | Recruiting

• 2 other identifiers: IRBNet 1848898-1GEHC ISRC_FPZ-23-03
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to evaluate if the diagnostic performance of 18F-flurpiridaz positron emission tomography (PET) myocardial perfusion imaging (MPI), given the radiotracer's properties, is non-inferior to the currently most widely utilized PET MPI radiopharmaceutical, 82Rb-chloride.

Conditions

Coronary Artery Disease; Coronary Microvascular Disease

Keywords

Myocardial Perfusion Imaging; Nuclear Cardiology; Positron Emission Tomography; Cardiac CT

Outcome Measures

Primary Outcomes (1)

• 18F-Flurpiridaz Diagnostic Performance

  The diagnostic performance of 18F-flurpiridaz compared to 82Rb-chloride PET myocardial perfusion imaging by expert readers using coronary CT angiography as the reference standard * Diagnostic performances will be analyzed on a per-vessel and a per-patient basis using coronary artery disease (CAD) ≥50% and ≥70% stenoses as significance cutoffs and CT-based fractional flow-reserve (FFR) ≤0.80 at the lesion level and at the distal vessel level

  From enrollment to completion of CT coronary angiography, an average of 10 days

Secondary Outcomes (2)

• Relative Perfusion Analysis

  From enrollment to completion of 18F-flurpiridaz PET MPI, an average of 10 days

• Myocardial Blood Flow Quantification

  From enrollment to completion of 18F-flurpiridaz PET MPI, an average of 10 days

Study Arms (1)

Patients Undergoing Myocardial Perfusion Imaging

Patients scheduled for a clinically indicated myocardial perfusion imaging study with 82Rb-chloride who subsequently undergo MPI with 18F-flurpiridaz as well as a CT coronary angiogram.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for a clinically indicated 82Rb-Chloride PET MPI at the West Los Angeles Veterans Affairs Medical Center / Greater Los Angeles Veterans Affairs Healthcare System.

You may qualify if:

• Patient scheduled for a clinically indicated 82Rb-chloride PET MPI
• Age ≥ 18 years
• Ability to provide consent

You may not qualify if:

• Previous participation in a 18F-flurpiridaz clinical trial
• Prior myocardial infarction
• Prior coronary revascularization (percutaneous coronary intervention and/or coronary artery bypass grafting)
• History of orthotopic heart transplantation
• Inability to control heart rate \< 65 bpm
• Frequent ventricular or atrial ectopy leading to irregular cardiac rhythm
• Creatinine ≥ 1.4 mg/dL
• Pregnant or breast-feeding status

Sponsors & Collaborators

• University of California, Los Angeles: lead
• VA Greater Los Angeles Healthcare System: collaborator

Study Sites (1)

West Los Angeles Veterans Affairs Medical Center

Los Angeles, California, 90073, United States

RECRUITING

Related Publications (20)

• Chen M, Almeida SO, Sayre JW, Karlsberg RP, Packard RRS. Distal-vessel fractional flow reserve by computed tomography to monitor epicardial coronary artery disease. Eur Heart J Cardiovasc Imaging. 2024 Jan 29;25(2):163-172. doi: 10.1093/ehjci/jead229.

  PMID: 37708371 BACKGROUND

• Sonck J, Nagumo S, Norgaard BL, Otake H, Ko B, Zhang J, Mizukami T, Maeng M, Andreini D, Takahashi Y, Jensen JM, Ihdayhid A, Heggermont W, Barbato E, Mileva N, Munhoz D, Bartunek J, Updegrove A, Collinsworth A, Penicka M, Van Hoe L, Leipsic J, Koo BK, De Bruyne B, Collet C. Clinical Validation of a Virtual Planner for Coronary Interventions Based on Coronary CT Angiography. JACC Cardiovasc Imaging. 2022 Jul;15(7):1242-1255. doi: 10.1016/j.jcmg.2022.02.003. Epub 2022 Apr 13.

  PMID: 35798401 BACKGROUND

• Griffin WF, Choi AD, Riess JS, Marques H, Chang HJ, Choi JH, Doh JH, Her AY, Koo BK, Nam CW, Park HB, Shin SH, Cole J, Gimelli A, Khan MA, Lu B, Gao Y, Nabi F, Nakazato R, Schoepf UJ, Driessen RS, Bom MJ, Thompson R, Jang JJ, Ridner M, Rowan C, Avelar E, Genereux P, Knaapen P, de Waard GA, Pontone G, Andreini D, Earls JP. AI Evaluation of Stenosis on Coronary CTA, Comparison With Quantitative Coronary Angiography and Fractional Flow Reserve: A CREDENCE Trial Substudy. JACC Cardiovasc Imaging. 2023 Feb;16(2):193-205. doi: 10.1016/j.jcmg.2021.10.020. Epub 2022 Feb 16.

  PMID: 35183478 BACKGROUND

• Abbara S, Blanke P, Maroules CD, Cheezum M, Choi AD, Han BK, Marwan M, Naoum C, Norgaard BL, Rubinshtein R, Schoenhagen P, Villines T, Leipsic J. SCCT guidelines for the performance and acquisition of coronary computed tomographic angiography: A report of the society of Cardiovascular Computed Tomography Guidelines Committee: Endorsed by the North American Society for Cardiovascular Imaging (NASCI). J Cardiovasc Comput Tomogr. 2016 Nov-Dec;10(6):435-449. doi: 10.1016/j.jcct.2016.10.002. Epub 2016 Oct 12.

  PMID: 27780758 BACKGROUND

• 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.

  PMID: 33521873 BACKGROUND

• Packard RRS, Lazewatsky JL, Orlandi C, Maddahi J. Diagnostic Performance of PET Versus SPECT Myocardial Perfusion Imaging in Patients with Smaller Left Ventricles: A Substudy of the 18F-Flurpiridaz Phase III Clinical Trial. J Nucl Med. 2021 Jun 1;62(6):849-854. doi: 10.2967/jnumed.120.252007. Epub 2020 Nov 27.

  PMID: 33246979 BACKGROUND

• Maddahi J, Bengel F, Czernin J, Crane P, Dahlbom M, Schelbert H, Sparks R, Phelps M, Lazewatsky J. Dosimetry, biodistribution, and safety of flurpiridaz F 18 in healthy subjects undergoing rest and exercise or pharmacological stress PET myocardial perfusion imaging. J Nucl Cardiol. 2019 Dec;26(6):2018-2030. doi: 10.1007/s12350-018-01484-z. Epub 2018 Nov 28.

  PMID: 30488323 BACKGROUND

• Packard RRS, Cooke CD, Van Train KF, Votaw JR, Sayre JW, Lazewatsky JL, Champagne KM, Orlandi C, Garcia EV, Maddahi J. Development, diagnostic performance, and interobserver agreement of a 18F-flurpiridaz PET automated perfusion quantitation system. J Nucl Cardiol. 2022 Apr;29(2):698-708. doi: 10.1007/s12350-020-02335-6. Epub 2020 Sep 7.

  PMID: 32895856 BACKGROUND

• Packard RRS, Votaw JR, Cooke CD, Van Train KF, Garcia EV, Maddahi J. 18F-flurpiridaz positron emission tomography segmental and territory myocardial blood flow metrics: incremental value beyond perfusion for coronary artery disease categorization. Eur Heart J Cardiovasc Imaging. 2022 Nov 17;23(12):1636-1644. doi: 10.1093/ehjci/jeab267.

  PMID: 34928321 BACKGROUND

• Packard RR, Huang SC, Dahlbom M, Czernin J, Maddahi J. Absolute quantitation of myocardial blood flow in human subjects with or without myocardial ischemia using dynamic flurpiridaz F 18 PET. J Nucl Med. 2014 Sep;55(9):1438-44. doi: 10.2967/jnumed.114.141093. Epub 2014 Jul 28.

  PMID: 25071096 BACKGROUND

• Maddahi J, Czernin J, Lazewatsky J, Huang SC, Dahlbom M, Schelbert H, Sparks R, Ehlgen A, Crane P, Zhu Q, Devine M, Phelps M. Phase I, first-in-human study of BMS747158, a novel 18F-labeled tracer for myocardial perfusion PET: dosimetry, biodistribution, safety, and imaging characteristics after a single injection at rest. J Nucl Med. 2011 Sep;52(9):1490-8. doi: 10.2967/jnumed.111.092528. Epub 2011 Aug 17.

  PMID: 21849402 BACKGROUND

• Chen J, Ding Y, Chen M, Gau J, Jen N, Nahal C, Tu S, Chen C, Zhou S, Chang CC, Lyu J, Xu X, Hsiai TK, Packard RRS. Displacement analysis of myocardial mechanical deformation (DIAMOND) reveals segmental susceptibility to doxorubicin-induced injury and regeneration. JCI Insight. 2019 Apr 18;4(8):e125362. doi: 10.1172/jci.insight.125362. eCollection 2019 Apr 18.

  PMID: 30996130 BACKGROUND

• Packard RRS, Luo Y, Abiri P, Jen N, Aksoy O, Suh WM, Tai YC, Hsiai TK. 3-D Electrochemical Impedance Spectroscopy Mapping of Arteries to Detect Metabolically Active but Angiographically Invisible Atherosclerotic Lesions. Theranostics. 2017 Jun 22;7(9):2431-2442. doi: 10.7150/thno.19184. eCollection 2017.

  PMID: 28744325 BACKGROUND

• Packard RR, Li D, Budoff MJ, Karlsberg RP. Fractional flow reserve by computerized tomography and subsequent coronary revascularization. Eur Heart J Cardiovasc Imaging. 2017 Feb;18(2):145-152. doi: 10.1093/ehjci/jew148. Epub 2016 Jul 28.

  PMID: 27469588 BACKGROUND

• Maddahi J, Packard RRS. PET should replace SPECT in cardiac imaging for diagnosis and risk assessment of patients with known or suspected CAD: Pro. J Nucl Cardiol. 2017 Dec;24(6):1955-1959. doi: 10.1007/s12350-015-0300-7. Epub 2017 Apr 10. No abstract available.

  PMID: 28397181 BACKGROUND

• Takx RA, Blomberg BA, El Aidi H, Habets J, de Jong PA, Nagel E, Hoffmann U, Leiner T. Diagnostic accuracy of stress myocardial perfusion imaging compared to invasive coronary angiography with fractional flow reserve meta-analysis. Circ Cardiovasc Imaging. 2015 Jan;8(1):e002666. doi: 10.1161/CIRCIMAGING.114.002666.

  PMID: 25596143 BACKGROUND

• Mc Ardle BA, Dowsley TF, deKemp RA, Wells GA, Beanlands RS. Does rubidium-82 PET have superior accuracy to SPECT perfusion imaging for the diagnosis of obstructive coronary disease?: A systematic review and meta-analysis. J Am Coll Cardiol. 2012 Oct 30;60(18):1828-37. doi: 10.1016/j.jacc.2012.07.038. Epub 2012 Oct 3.

  PMID: 23040573 BACKGROUND

• Maddahi J, Lazewatsky J, Udelson JE, Berman DS, Beanlands RSB, Heller GV, Bateman TM, Knuuti J, Orlandi C. Phase-III Clinical Trial of Fluorine-18 Flurpiridaz Positron Emission Tomography for Evaluation of Coronary Artery Disease. J Am Coll Cardiol. 2020 Jul 28;76(4):391-401. doi: 10.1016/j.jacc.2020.05.063.

  PMID: 32703509 BACKGROUND

• Berman DS, Maddahi J, Tamarappoo BK, Czernin J, Taillefer R, Udelson JE, Gibson CM, Devine M, Lazewatsky J, Bhat G, Washburn D. Phase II safety and clinical comparison with single-photon emission computed tomography myocardial perfusion imaging for detection of coronary artery disease: flurpiridaz F 18 positron emission tomography. J Am Coll Cardiol. 2013 Jan 29;61(4):469-477. doi: 10.1016/j.jacc.2012.11.022. Epub 2012 Dec 19.

  PMID: 23265345 BACKGROUND

• Packard RRS. The clinical promise of 18F-flurpiridaz PET imaging heralds a new frontier in the diagnosis and management of coronary artery disease. Nat Cardiovasc Res. 2025 Jan;4(1):1-4. doi: 10.1038/s44161-024-00587-w. No abstract available.

  PMID: 39825085 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Microvascular Angina

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-in-Residence, Departments of Medicine (Cardiology) and Physiology

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 12, 2026
• Study Start: August 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)