Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced preliminary Phase 2 data describing the methodology used to define an imaging protocol for a one-day rest-stress myocardial perfusion imaging test using its novel investigational PET imaging agent flurpiridaz F 18 injection (formerly known as BMS747158). Flurpiridaz F 18 injection is in development for use with Positron Emission Tomography (PET) for myocardial perfusion imaging (MPI) to detect coronary artery disease. Data suggest that the uptake properties of flurpiridaz F 18 injection make it possible to allow for a relatively low dosing ratio and a delay of between 30 minutes and one hour between rest and stress injections, depending on the mode of stress used.
“This novel approach of modeling different dosages and time intervals based on baseline image data not only enabled recognition of optimal acquisition parameters for image quality and dosimetry, but dramatically shortened development time that otherwise would have depended on trial and error methodology”
Lantheus, together with its partner in this method development, Cardiovascular Imaging Technologies of Kansas City, Mo., developed an innovative technique to determine the dependence of the rest-to-stress dosing ratio in order to identify the minimum delay between the two injections for a one-day rest-stress test. The data were featured today in an oral presentation (# 798451) by Joel Lazewatsky, Ph.D., Principal Research Scientist, Lantheus Medical Imaging, Inc., and in a poster presentation (# 799099) on Tuesday, June 8 by James A. Case, Ph.D., Director of Physics at Cardiovascular Imaging Technologies, at the SNM 57th Annual Meeting in Salt Lake City.
"Our team used data derived from a Phase 2 clinical study of flurpiridaz F18 injection PET MPI to define the optimal delay between rest and stress dosing as part of an effort to determine the lowest total dose needed to obtain good quality images," said Dr. Lazewatsky. "We are currently validating this model with the second cohort of patients from the Phase 2 clinical study and we look forward to the results."
To identify the appropriate amounts of rest and stress dosing for hypothetical same-day rest and stress dosing, computer simulations of same-day rest and stress images were developed using actual rest and stress image data obtained from 20 patients who were each imaged on a two-day basis. The actual rest and stress images from the separate days together with the computer simulations of same-day images were each reviewed in a blinded fashion by three experienced readers.
In evaluating the maximum residual contribution of the imaging agent initially used in the rest study to the subsequent stress image which did not produce a meaningful change in the reader's perception of the stress image, it was determined for stress induced by adenosine (a pharmacological stress agent) that a minimum dosing ratio of 2.0 (twice as much imaging agent used in stress as compared to rest) was required with a 30 minute delay between injections. For stress induced by exercise, a minimum dosing ration of 3.0 (three times as much imaging agent used in stress as compared to rest) was needed with a one hour delay between injections.
"Using this novel approach, we expect to validate a protocol that fits into current clinical practice and that can be administered at the lowest possible dose for patients undergoing a same-day rest-stress test with flurpiridaz F 18 injection," said Dana Washburn, M.D., Vice President, Clinical Development and Medical Affairs, Lantheus Medical Imaging, Inc. "We developed this novel methodology to define the rest and stress doses as well as the optimal delay between the two doses without having to involve a large number of patients."
Drs. Lazewatsky and Case led the collaboration between Lantheus and Cardiovascular Imaging Technologies to develop this unique approach to protocol optimization. "This novel approach of modeling different dosages and time intervals based on baseline image data not only enabled recognition of optimal acquisition parameters for image quality and dosimetry, but dramatically shortened development time that otherwise would have depended on trial and error methodology," said Dr. Case.
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