Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced preliminary data from a single site participating in the multicenter Phase 2 clinical trial that showed that Positron Emission Tomography (PET) imaging with its novel investigational agent flurpiridaz F 18 injection (formerly known as BMS747158) provided better image quality than technetium-99m sestamibi single photon emission computed tomography (SPECT), the current standard for the non-invasive detection of coronary artery disease (CAD). The data also indicated that PET imaging with flurpiridaz F 18 injection rendered a significantly larger perfusion defect size when compared with the corresponding defects seen in SPECT imaging. The data were featured today in an oral presentation (# 798032) by Balaji Tamarappoo, M.D., Clinical Fellow, Advanced Cardiac Imaging at Cedars-Sinai Medical Center, at the SNM 57th Annual Meeting in Salt Lake City.
“We are enthusiastically committed to the progression of our PET clinical programs, as we believe that more accurate evaluation of patients with cardiovascular disease can result in better patient care and outcomes, and may ultimately help to control healthcare costs.”
"These encouraging preliminary data from our clinical research site show that PET imaging with flurpiridaz F 18 injection provided improved image quality and an increase in defect size compared to SPECT," said Daniel S. Berman, M.D., Chief, Cardiac Imaging and Nuclear Cardiology, Cedars-Sinai Medical Center. "A PET imaging agent that may provide higher quality images with more obvious perfusion defects can have a profound effect on physicians' ability to make more definitive assessments of coronary artery disease."
Twenty-six patients in a single study center underwent SPECT and PET imaging within six months. PET myocardial perfusion imaging was performed with flurpiridaz F 18 injection at rest and was then followed one hour later with imaging at exercise or under pharmacologically-induced (adenosine) stress. PET and SPECT image quality were assessed by two independent, blinded readers and graded as excellent, good or fair. Stress and rest perfusion defects on PET and SPECT were assessed by the same readers by computer-assisted visual interpretation using the standard 17 segment, 5-point scoring model.
Findings showed that image quality with flurpiridaz F 18 PET was excellent in 24 and good in 2 patients, in contrast to image quality with SPECT which was excellent in 17, good in 8 and fair in 1 patient(s) (p<0.001). In 14 patients with abnormal SPECT (SSS≥4), mean SDS was greater with PET than with SPECT (9.6 ± 1.8 vs. 5.4 ± 0.7.
"Although these data will need to be confirmed by results from other sites and from subsequent larger clinical trials, they suggest that flurpiridaz F 18 PET myocardial perfusion imaging may provide improved image quality and an increase in defect size compared to SPECT," said Dana Washburn, M.D., Vice President, Clinical Development and Medical Affairs, Lantheus Medical Imaging, Inc. "The data also suggest that PET imaging with flurpiridaz F 18 injection can be performed using exercise or pharmacological stress, which offers a potential advantage over existing PET MPI agents on the market."
"The presentation of 14 abstracts on our pipeline products at this year's SNM Annual Meeting reflects the level of interest by the medical community in learning more about innovations in nuclear medicine and the potential of PET technology to detect and evaluate cardiovascular disease," stated Don Kiepert, President and Chief Executive Officer, Lantheus Medical Imaging, Inc. "We are enthusiastically committed to the progression of our PET clinical programs, as we believe that more accurate evaluation of patients with cardiovascular disease can result in better patient care and outcomes, and may ultimately help to control healthcare costs."
SOURCE Lantheus Medical Imaging, Inc.