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 Explores Magnetic Nanoparticles as Bimodal Imaging Agent for PET/MRI

Image courtesy of MR Solutions.

News | PET-MRI | May 23, 2019
Researchers from Bourgogne University in Dijon, France, showed that use of superparamagnetic iron oxide nanoparticles (...
Proton Therapy Lowers Risk of Side Effects Compared to Conventional Radiation
News | Proton Therapy | May 23, 2019
Cancer patients getting proton therapy instead of traditional photon radiation are at a significantly lower risk of...
VolparaDensity With Tyrer-Cuzick Model Improves Breast Cancer Risk Stratification
News | Breast Density | May 22, 2019
Research has demonstrated use of Volpara Solutions' VolparaDensity software in combination with the Tyrer-Cuzick Breast...
Partial Breast Irradiation Effective, Convenient Treatment Option for Low-Risk Breast Cancer
News | Radiation Therapy | May 20, 2019
Partial breast irradiation produces similar long-term survival rates and risk for recurrence compared with whole breast...
AI Detects Unsuspected Lung Cancer in Radiology Reports, Augments Clinical Follow-up
News | Artificial Intelligence | May 20, 2019
Digital Reasoning announced results from its automated radiology report analytics research. In a series of experiments...
New Study Evaluates Head CT Examinations and Patient Complexity
News | Neuro Imaging | May 17, 2019
Computed tomography (CT) of the head uses special X-ray equipment to help assess head injuries, dizziness and other...
New Phase 2B Trial Exploring Target-Specific Myocardial Ischemia Imaging Agent
News | Radiopharmaceuticals and Tracers | May 17, 2019
Biopharmaceutical company CellPoint plans to begin patient recruitment for its Phase 2b cardiovascular imaging study in...
Managing Architectural Distortion on Mammography Based on MR Enhancement
News | Mammography | May 15, 2019
High negative predictive values (NPV) in mammography architectural distortion (AD) without ultrasonographic (US)...
Icon Launches New Clinical Trial Patient Engagement Platform
Technology | Patient Engagement | May 14, 2019
Icon plc announced the release of its web-based clinical trial patient engagement platform, to provide patients with...
Blue Earth Diagnostics Expands Access to Axumin in Europe
News | Radiopharmaceuticals and Tracers | May 13, 2019
Blue Earth Diagnostics announced expanded access to the Axumin (fluciclovine (18F)) imaging agent in Europe. The first...