Medical context
Medical context
The medical context – why are we developing the SYN2 cardiotracer?
Coronary artery disease (ischemic heart disease) is one of the biggest challenges facing modern medicine. According to the World Health Organization, cardiovascular diseases cause more than 17 million deaths a year, almost half of those due to myocardial ischemia. In Poland there are about 100,000 hospitalizations every year due to heart attack, and millions of patients live with chronic coronary artery disease. The disease severely reduces quality of life and is associated with a high risk of complications, including cardiac arrest.
Why are new diagnostic methods needed?
Quick and precise diagnosis is crucial for preventing complications and for choosing the right treatment. Currently the “gold standard” remains coronary angiography – an invasive examination of coronary vessels. Although effective, it requires hospitalization, carries the risk of complications, and generates high costs.
Therefore, cardiology is seeking to limit its use solely to therapeutic purposes and to replace it with non-invasive diagnostic methods.
SPECT and PET/CT
Why are better tracers needed?
Currently the most commonly used method for evaluating perfusion is SPECT (single photon emission computed tomography), but it has significant limitations: long examination time, higher dose of radiation, and lower image quality. Moreover, SPECT does not allow for quantitative measurement of blood flow.
A much more advanced method is PET/CT (positron emission tomography / computed tomography), which achieves:
- Higher image resolution,
- Shorter examination time,
- The capability of precise quantitative measurement of coronary flow.
Despite its technological advantages, PET/CT is not yet commonly used in cardiology, mainly due to the limited availability of appropriate radiotracers. Worldwide, there are just four perfusion tracers available for PET/CT, and three of them have serious technological limitations.
Why is isotope half-life so important?
Radiopharmaceuticals contain radioactive isotopes whose activity gradually wanes. The half-life is the time it takes for activity to fall by half. The shorter the half-life, the faster the preparation loses its diagnostic usefulness and the more difficult it is to deliver. For example, if the half-life is one hour, after an hour only half of the produced preparation remains.
This entails major logistical constraints. The existing tracers – based on the isotopes of rubidium 82Rb, oxygen 15O and nitrogen 13N – have a very short half-life, from a few seconds to a few minutes. Tu use oxygen 15O and nitrogen 13N, the diagnostic centre must have a cyclotron literally next to the examination site, which is costly and unattainable for most facilities.
Why is SYN2 a breakthrough?
SYN2 is based on the fluorine isotope 18F, which has a half-life of 109 minutes. This is long enough to:
- Manufacture the tracer at specialized plants,
- Transport it long distances,
- Retain the appropriate activity until it is administered to the patient.
This approach enables broad application of PET/CT diagnostics in cardiology – much as it happened in oncology following introduction of the tracer FDG (fluorodeoxyglucose).
Manufacturing efficiency
The advantage of cyclotron synthesis over generators
Some PET/CT tracers are produced in generators, which, although convenient, are expensive to buy and less efficient. Their effectiveness declines over time, regardless of the number of tests performed.
In the case of radiopharmaceuticals produced using a cyclotron (such as SYN2):
Unit costs fall along with the increasing number of examinations,
Production can be scaled,
Manufacturing and distribution can be centralized at greater distances.
All of this means that SYN2 has the potential to become the new standard in non-invasive diagnosis of coronary artery disease.