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Background
Background

 

Medical isotopes are an integral part of medical practice and are used in a range of radio-pharmaceuticals for many clinical imaging protocols and also in some therapeutic strategies. They have a critical role in diagnosis, prognosis and treatment decision-making and also in the follow up and re-evaluation of patients after they have been treated. The most commonly used medical isotope in clinical decision making is Technetium-99m (Tc-99m). Over 20 million procedures a year are performed in the US with this medical isotope; in Canada the isotope is used in approximately 1.8 million procedures.

 Tc-99m is derived from a precursor isotope, Molybdenum-99 (Mo-99), which is produced in 6 (mostly) aging nuclear reactors that are heavily subsidized by national governments, and which do not have a robust supply chain or business model. The reactor in Chalk River, Canada, is approximately 55 years old and manufactures over 40% of the world’s supply of Mo-99. On May 18, 2009 the NRU reactor Chalk River had its 2nd major unscheduled shut down in less than 2 years. With this recent emergency shut down, and subsequently that in Petten, Netherlands (also contributing about 40% of world supply), there has been a major worldwide disruption in the supply of medical isotopes, which has caused significant impediments to best practices in clinical care. Although Chalk River has now been repaired and has come back on line, the Government of Canada has indicated that it is unlikely to remain open beyond 2016. Petten may also close in 2018.

The Government has indicated a desire to support research and development into alternative methods of Tc-99m manufacture, and also alternative radio-pharmaceuticals which achieve the same clinical purpose but which do not use Tc-99m as the radiolabel.

Our imaging clinical trials network (MITNEC) in the immediate future will address the objectives of the Federal "Isotope Supply Initiative", which are focused on reducing our clinical reliance on the 99mTc currently produced by nuclear reactors. The central objective of MITNEC is to move innovations in imaging toward their broad application in clinical research and facilitate the uptake of research outcomes into clinical practice and improved patient care. MITNEC will initially encompass 3 medical disciplines -oncology, cardiology and neurology- with themes such as immunology and inflammation representing cross-sectional processes relevant to our major disciplines.

MITNEC will be national in scope with participation from 13 universities located in five provinces across Canada. We will assemble a critical mass of scientific and medical expertise and link hospitals, research centers and existing clinical trial networks in Canada to establish common standard operating procedures (SOPs) and protocols and coordinate the network’s research activities in clinical trials. The goals of MITNEC are: 1- To provide a national multicenter imaging trials network to validate radiopharmaceuticals (including novel agents developed through CIHR/NSERC awards) and strategies to reduce our reliance on 99mTc; 2- To provide a national imaging trials network to validate Tc-99m produced by the alternative production methods supported by the NRCan awards; 3- To establish a robust, integrated, national multicenter imaging trials network to support future research in imaging biomarkers; 4- To build the infrastructure that will attract future investments in multicenter imaging clinical trials.