News | May 18, 2011

PET Myocardial Perfusion Imaging With Flurpiridaz F18 Offers Superior Imaging Over SPECT

May 18, 2011 – Lantheus Medical Imaging Inc. announced data from a phase 2 clinical trial that demonstrated positron emission tomography (PET) myocardial perfusion imaging with flurpiridaz F18 provided superior image quality, diagnostic certainty and diagnostic performance for detecting coronary artery disease (CAD) compared to single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), the current standard for the noninvasive detection of CAD. The data also demonstrated a positive safety profile for PET imaging with flurpiridaz F18. The data were featured today in a late-breaking presentation by Jamshid Maddahi, M.D., FACC, professor of molecular and medical pharmacology (nuclear medicine) and medicine (cardiology) at the David Geffen School of Medicine at UCLA, and lead principal investigator of the study, at ICNC10 - Nuclear Cardiology and Cardiac CT Conference in Amsterdam.

“Results from this phase 2 trial show that PET myocardial perfusion imaging with flurpiridaz F18 demonstrates a strong safety profile and is superior to SPECT imaging with respect to the quality of rest and stress images, certainty of image interpretation and diagnostic performance as measured by standard ROC analysis for detecting CAD,” said Maddahi. “Overall, this enhanced diagnostic performance may lead to more accurate testing and more appropriate patient management decisions in comparison to other noninvasive diagnostic modalities and, as such, we see great value in proceeding to phase 3 clinical trials.”

In the phase 2 trial, 143 patients from 21 centers underwent rest and stress PET and SPECT myocardial perfusion imaging and were evaluated for safety. Of these patients, 86 underwent coronary angiography and formed the population for evaluating diagnostic performance. PET myocardial perfusion imaging was performed with flurpiridaz F18 at rest and at stress utilizing pharmacological coronary vasodilation or treadmill exercise. It is important to note that flurpiridaz F18 can be used in conjunction with treadmill exercise, which is not feasible with the more commonly used alternative PET tracers for myocardial perfusion imaging.

Results showed that a significantly higher percentage of images were rated as either excellent or good quality with PET imaging, compared to SPECT imaging for stress images (98.8% vs. 84.9%, p

In March 2011, Lantheus received special protocol assessment approval from the U.S. Food and Drug Administration (FDA) for the phase 3 trial of flurpiridaz F18. The phase 3 clinical development program will include two open-label, multicenter trials to assess the diagnostic efficacy (both sensitivity and specificity) of flurpiridaz F18 PET MPI, compared with SPECT myocardial perfusion imaging in the detection of significant coronary artery disease. The trials will enroll a total of approximately 1,350 patients at approximately 100 sites globally. Coronary angiography will be the truth standard for all patients. The clinical development program includes hypotheses for superiority for sensitivity and non-inferiority for specificity with an adequate sample size to demonstrate superior specificity if present. An interim analysis will take place upon 50 percent enrollment of the first trial.

Flurpiridaz F18 injection, a fluorine 18-labeled agent that binds to mitochondrial complex 1 (MC-1), was designed to be a novel myocardial perfusion PET imaging agent for the diagnosis of CAD. PET imaging with flurpiridaz F18 has the potential to be a new clinical tool for the evaluation of myocardial perfusion that may better evaluate patients with known or suspected CAD in comparison to other noninvasive diagnostic modalities.

For more information: visit www.lantheus.com

Related Content

Study Demonstrates First Human Application of Novel PET Tracer for Prostate Cancer

Transaxial 11Csarcosine hybrid PET/CT showed a (triangulated) adenocarcinoma in the transition zone of the anterior right prostate gland on PET (A), CT (B), and a separately obtained T2?weighted MR sequence (C) with resulting PET/MRI registration (D). Image courtesy of M. Piert et al., University of Michigan, Ann Arbor, Mich.

News | Radiopharmaceuticals and Tracers | August 16, 2017
In the featured translational article in the August issue of The Journal of Nuclear Medicine, researchers at the...
MRI Reveals Striking Brain Differences in People with Genetic Autism

Example images for a control participant , a deletion carrier, and a duplication carrier. In the sagittal image of the deletion carrier, the thick corpus callosum, dens and craniocervical abnormality, and cerebellar ectopia are shown. For the duplication carrier, the sagittal image shows the thin corpus callosum and the axial image shows the increased ventricle size and decreased white matter volume. Image courtesy of the Radiological Society of North America (RSNA).

News | Neuro Imaging | August 09, 2017
August 9, 2017 — In the first major study of its kind, researchers using magnetic...
Clinical Data Supports Use of Xoft System for Endometrial Cancer
News | Brachytherapy Systems | August 03, 2017
Researchers presented clinical data supporting use of the Xoft Axxent Electronic Brachytherapy (eBx) System for the...
brain with chronic traumatic injury
News | Magnetic Resonance Imaging (MRI) | August 02, 2017
Fighters are exposed to repeated mild traumatic brain injury (mTBI), which has been associated with neurodegenerative...
NIH-funded scientists have discovered that Parkinson’s disease increases the amount of “free” water in a particular brain area

NIH-funded scientists have discovered that Parkinson’s disease increases the amount of “free” water in a particular brain area. Image courtesy of David Vaillancourt, Ph.D., University of Florida.

News | Neuro Imaging | July 31, 2017
Scientists at the University of Florida have discovered a new method of observing the brain changes caused by Parkinson...
more healthcare providers and patients are choosing options such as Gamma Knife stereotactic radiosurgery
News | Radiation Therapy | July 31, 2017
Each year, up to 650,000 people who were previously diagnosed with various forms of cancer will develop brain...
"Residual Echo" of Ancient Humans May Hold Clues to Mental Disorders

MRI data shows (left) areas of the skull preferentially affected by the amount of Neanderthal-derived DNA and (right) areas of the brain’s visual system in which Neanderthal gene variants influenced cortex folding (red) and gray matter volume (yellow). Image courtesy of Michael Gregory, M.D., NIMH Section on Integrative Neuroimaging

News | Neuro Imaging | July 26, 2017
Researchers from the National Institute of Mental Health (NIMH) have produced the first direct evidence that parts of...
New York Hospital Finds Significant Cost Savings With Toshiba’s Aquilion One CT
News | Computed Tomography (CT) | July 25, 2017
In five years, Kaleida Health’s Stroke Care Center (SCC) at the Gates Vascular Institute in Buffalo, N.Y., has realized...
Radiotherapy Prior to Surgery Reduces Secondary Tumor Risk in Early-Stage Breast Cancer Patients
News | Radiation Therapy | July 24, 2017
Moffitt Cancer Center researchers launched a first-of-its-kind study comparing the long-term benefits of radiation...
Overlay Init