Clinical Studies
Clinical Studies
Clinical Imaging Trials of Novel Drugs
MITRO is unique in that it has established a network of radiopharmaceutical tracer production, and imaging centers for PET acquisition and image analysis utilizing the most advanced neuroimaging tracer compounds available to be used in China and Asia. Supported by experienced, well-established study teams in China, Europe and the US, MITRO provides the capability for PET radiotracer production and PET acquisition. These services support multi-center trials in China and Asia which require PET for study eligibility, disease evaluation, and treatment efficacy.
PET Production Center
PET production facilities in the MITRO Network are located at Class-4 Hospitals in China and MITRO is currently expanding to other regions in Asia. Class-4 hospitals are hospitals certified by the Nation Medical Products Administration (NMPA), formerly known as CFDA, to manufacture and use novel PET tracers in clinical imaging studies (likened to the US FDA Radioactive Drug Research Committee). For hospitals with this status, injection and PET imaging must occur within the same facility/site as the radiotracer production; distribution of the PET tracer to other facilities including other Class-4 hospitals is not allowed.