Lantheus to Present New Data at the ASNC Annual Scientific Session on the Novel PET Cardiac Imaging Agent Flurpiridaz F 18 in Patients with Suspected Heart Disease Undergoing Exercise Stress Testing
Findings Show Superiority of Flurpiridaz F 18 PET MPI Compared to SPECT MPI for the Assessment of Coronary Artery Disease During Exercise Stress Testing
The oral presentation entitled, “Exercise Stress Testing with
Flurpiridaz F 18 PET and Tc99m SPECT Myocardial Perfusion Imaging for
the Assessment of CAD: A Subset Analysis of the Flurpiridaz F 18 301
Phase 3 Study,” will be presented by
“Due to short half-life limitations of currently available tracers (13NH3 and 82Rb), PET myocardial perfusion imaging is commonly used in conjunction with pharmacologic stress testing,” said Dr. Beanlands, the lead author of the presentation. “The ability to perform PET imaging with exercise stress would allow us to gather important additional clinical information and also to use the same camera for both stress modalities. The results of this study provide evidence of the particular utility and future potential of flurpiridaz F 18 PET imaging for the diagnosis of coronary artery disease.”
Based on a blinded read of PET and SPECT data, flurpiridaz F 18 PET imaging demonstrated a statistically greater sensitivity (67.0%) versus SPECT (54.9%) (p<0.016) but lower specificity (73.8%) versus SPECT (85.4%) (non-significant for non-inferiority testing). Improved diagnostic performance of flurpiridaz F 18 PET imaging versus SPECT was also observed by ROC analysis (p<0.05). A significantly higher percentage of images were rated as either excellent or good quality with flurpiridaz F 18 PET imaging, compared to SPECT for rest images (p<0.001). No drug-related serious adverse events were observed.
The data are from a multicenter, international (
"The Phase 3 data sub-analysis presented at ASNC demonstrates the
ability to conduct flurpiridaz F 18 PET imaging for coronary artery
disease detection in association with exercise stress testing,” said
About the Flurpiridaz F 18 First Phase 3 Study
The first flurpiridaz F 18 Phase 3 study was designed to assess the diagnostic efficacy of flurpiridaz F 18 PET imaging versus SPECT with Tc99m-labeled agents for CAD detection in the same patients. Patients with known or suspected CAD who were either scheduled for or had completed invasive coronary angiography (without intervention) were included in the study. Each patient was studied using both one-day rest/stress flurpiridaz F 18 PET imaging and Tc99m-labeled SPECT imaging (one-day rest/stress or two-day protocol). Images were interpreted by three expert readers blinded to all clinical information. Quantitative coronary angiography (QCA) was used as the truth standard, with patients considered CAD positive with a stenosis ≥ 50% in at least one major vessel by QCA. Flurpiridaz F 18 PET imaging substantially outperformed SPECT, in sensitivity, one of the study’s primary endpoints, but did not meet the study’s other primary endpoint, non-inferiority for specificity, implying a substantial and unexpected under-diagnosis of CAD with SPECT in the trial. Unlike flurpiridaz F 18 PET imaging, SPECT results were skewed with low sensitivity and high specificity when compared to the truth standard. In secondary endpoints, flurpiridaz F 18 PET imaging outperformed SPECT in image quality and diagnostic certainty with less than half of the radiation exposure for patients. Subsequent to the initial read of the data, LMI performed a re-read which confirmed the initial results as well as showed improved performance of flurpiridaz F 18 PET imaging as compared to SPECT in women and subjects with high body mass index. Based on the results of the first Phase 3 study, the Company redesigned the protocol for its second Phase 3 study, including different primary endpoints – namely, the performance of flurpiridaz F 18 on its own merit versus coronary angiography as the truth standard – and the Company has received a Special Protocol Assessment from the
About Flurpiridaz F 18 and Coronary Artery Disease
Flurpiridaz F 18, a fluorine 18-labeled agent that binds to mitochondrial complex 1 (MC-1)1, was designed to be a novel PET imaging agent that may better evaluate patients with known or suspected CAD, which is the most common form of heart disease2, affecting an estimated 15.5 million Americans 20 years of age or older3. CAD is the leading cause of death in
About PET and MPI
PET imaging or a PET scan is a type of nuclear medicine imaging procedure4 that provides information about the function and metabolism of the body’s organs, unlike computed tomography (CT) or magnetic resonance imaging (MRI), which primarily show anatomy and structure5. MPI is a non-invasive test that utilizes a small amount of radioactive material (radiopharmaceutical) injected into the body to depict the distribution of blood flow to the heart. MPI is used to identify areas of reduced blood flow to the heart muscle. The test is typically conducted under both rest and stress conditions, after which physicians examine and compare the two scans and predict whether the patient has significant coronary artery disease6. Although SPECT is most commonly used for MPI7, PET imaging has gained considerable support and use in the field of cardiovascular imaging, as it offers many advantages to SPECT, including higher spatial and contrast resolution, resulting in higher image quality and improved diagnostic accuracy, accurate attenuation correction and risk stratification8.
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1 Yalamanchili, P, Wexler, E, Hayes, M, Yu, M, MD, Bozek J, Radeke, H, Azure, M, Purohit, A, Casebier, DS, and Robinson, SP. Mechanism of uptake and retention of 18F BMS-747158-02 in cardiomyocytes: A novel PET myocardial imaging agent. Journal Nuclear Cardiology 2007 Nov-Dec;14(6):782-8.
3 Heart Disease and Stroke Statistics. 2016 Update: A Report
4 Radiology Info. What is Positron Emission Tomography –
Computed Tomography (PET/CT) Scanning. http://www.radiologyinfo.org/en/info.cfm?pg=PET.
7 Salerno, M and Beller, GA, Noninvasive Assessment of Myocardial Perfusion. Circ Cardiovasc Imaging. 2009; 2:412-424.
8 Heller, G, Calnon, D and Dorbala, S. Recent Advances in Cardiac PET and PET/CT Myocardial Perfusion Imaging. J Nucl Cardiol 2009; 16:962-9.
Meara Murphy, 978-671-8508