A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
Summary
The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI).
Timeline
- Start
- 2011-06
- Primary completion
- 2013-07
- Completion
- 2013-09
Outcome
Mixed primary results
registry NUMBER Flurpiridaz F18 PET MPI: PET MPI sensitivity: .719 (.670 to .763) Proportion of true positive cases NCT01347710 ↗
registry NUMBER Flurpiridaz F18 PET MPI: SPECT MPI Sensitivity: .537 (.485 to .588) Proportion of true positive cases NCT01347710 ↗
registry Flurpiridaz F18 PET MPI; p <0.001; McNemar; note: P-value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule NCT01347710 ↗
paper specificity did not meet the prespecified noninferiority criterion (76.2% [95% CI: 71.8% to 80.1%] vs. 86.6% [95% CI: 83.2% to 89.8%]; p = NS). PMID 32703509 ↗
Publications
- Lopez DM, Huck DM, Divakaran S, Brown JM, Weber BN, Lemley M, Builoff V, Shanbhag A, Lan Z, Buckley C, Al-Mallah MH, Dorbala S, Blankstein R, Slomka P, Di Carli MF. Utility of 18F-Flurpiridaz PET Relative Flow Reserve in Differentiating Obstructive From Nonobstructive Coronary Artery Disease. Circ Cardiovasc Imaging. 2025 Nov;18(11):e018323. doi: 10.1161/CIRCIMAGING.125.018323. Epub 2025 Oct 9.
- Poitrasson-Riviere A, Moody JB, Renaud JM, Hagio T, Arida-Moody L, Buckley CJ, Al-Mallah MH, Nallamothu BK, Weinberg RL, Ficaro EP, Murthy VL. Integrated myocardial flow reserve (iMFR) assessment: optimized PET blood flow quantification for diagnosis of coronary artery disease. Eur J Nucl Med Mol Imaging. 2023 Dec;51(1):136-146. doi: 10.1007/s00259-023-06455-2. Epub 2023 Oct 9.
- Hagio T, Moody JB, Poitrasson-Riviere A, Renaud JM, Pierce L, Buckley C, Ficaro EP, Murthy VL. Multi-center, multi-vendor validation of deep learning-based attenuation correction in SPECT MPI: data from the international flurpiridaz-301 trial. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1028-1033. doi: 10.1007/s00259-022-06045-8. Epub 2022 Nov 19.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 99mTc sestamibi | Diagnostic / imaging agent | — | — |
| Subject | BMS747158 | Diagnostic / imaging agent | — | — |
| Subject | TECHNETIUM TETROFOSMIN | Diagnostic / imaging agent | — | — |