On Tuesday, Royal Philips announced a partnership with PET imaging agent manufacturer, FluoroPharma Medical Inc., to provide data management for the Phase II clinical trials investigating its CardioPET agent.

CardioPET is an F-18-labeled, modified fatty acid that enters the heart the same way that natural fatty acids do, and can be used to assess the regions in the myocardium with decreased blood flow or metabolic insufficiency.

"It has been known for some time that a fatty acid tracer can detect coronary artery disease (CAD), specifically ischemia, based on work done with single-photon (SPECT) fatty acid molecules," Edward L. Lyons, Jr., vice president of development at FluoroPharma, told HCB News.

FluoroPharma worked with Philips to put the image data generated by CardioPET through a quality assurance process. Philips' advanced molecular imaging technology was used to verify that the same standards were applied to data across clinical sites.

During an ischemic episode, the heart muscle's metabolism changes from fatty acids to glucose, to put the heart muscle in a "survival mode" until blood flow is adequately restored. Previous research has shown that abnormality can persist for up to 30 hours, which is called the ischemic memory.

"If CardioPET could identify ischemic memory, it could have implications for how we do stress testing; with or without exercise, for example," said Lyons.


The Phase II study was conducted in Belgium, and tested how well CardioPET can spot CAD in patients with SPECT scans that indicate the disease.

The researchers reported that there were no serious adverse events, and that the images showed evidence of CAD in patients who were confirmed to have the disease with SPECT and invasive angiography.

Going forward, FluoroPharma and Philips will work to improve image quality, and potentially design new approaches that are tailored to specific features of CardioPET.

“It is critical to ensure that the optimal image processing methodology is applied during the evaluation of performance of new radiotracers,” said Piotr Maniawski, director of clinical science, Advanced Molecular Imaging at Philips, in prepared remarks. “Working with FluoroPharma very early in the process of data collection and evaluation provides Philips with a unique opportunity to be a part of an effort aimed at improving molecular imaging in cardiology.”

Fatty acid metabolism is affected by different pathologies — it can be elevated in diabetics or its oxidation can be impaired in heart failure patients. Lyons believes it's important to quantitatively analyze tracer kinetics in the presence of those conditions, to assess the response of therapeutic drugs over the long term.

"Quantitative assessment is an inherent strength of PET imaging, so new frontiers that assist medical decision-making could be forged here, with the long-term goal of earlier and more appropriate interventions at less cost," said Lyons.

The Phase II data was presented at the European Association of Nuclear Medicine (EANM) Annual Congress in Barcelona, Spain this week. The congress brought together over 6,000 nuclear medicine practitioners and stakeholders.

In September, data from the trial was presented at the 21st Annual Meeting of the American Society of Nuclear Cardiology (ASNC) in Boca Raton, Florida.

Dr. Gary Heller of Morristown (New Jersey) Medical Center presented the study results. Dr. Heller, an ASNC past president, co-authored the study with the principal investigator, Professor Olivier Gheysens, the Phase II clinical investigators in Belgium, and Dr. Manuel Cerqueira of the Cleveland Clinic.

"We found that the image quality for CardioPET was significantly better than the comparative SPECT studies," said Heller at the time. "Diagnostically, CardioPET correctly identified ischemia in both exercise and pharmacologic stress studies, and the overall diagnostic accuracy for CardioPET was confirmed to be comparable to that of SPECT."