18FDG Clinical Trial
Official title:
Clinical Trial to Evaluate the Safety and Clinical Utility of18F-FDG Produced by the Molecular Imaging and Research Centre of Nova Scotia
18F-FDG produced in the MIRC NS has a similar safety profile to the same compound utilized elsewhere in that no significant adverse events will occur during observation of the patients for 2 1/2 hours post injection of the tracer. It is also hypothesized that as this FDG produced by similar methodology and its quality assurance assessed as in another jurisdictions will have similar performance parameters in patients with focal lung pathology to that previously determined.
Positron Emission Tomography (PET) utilizing 18F-FDG is a nuclear medicine imaging technique
evaluating glucose related metabolic processes providing information not obtainable from
anatomic imaging . 18F-FDG PET scanning is used clinically in most developed countries and
Canadian jurisdictions primarily in oncology patients and also in assessing myocardial
viability and some neurological conditions.
The functional information obtained from 18F-FDG PET has been demonstrated to have a
significant impact on patient management in oncology.1 It is used to provide accurate
pre-treatment staging, aid in planning of therapy, monitoring response to therapy,
restaging, providing assessment of recurrence after curative therapy and in radiation
treatment planning.
Patients with severe ischemic heart disease and secondary myocardial dysfunction pose
difficult management decisions in terms of surgical vs. medical management. Assessment of
viable myocardium is integral in this decision and 18F-FDG PET has been shown one of the
most effective non-invasive methods in this evaluation.
18F-FDG PET has been shown very effective in neurology differentiating dementia types and in
patients with epilepsy in whom surgical treatment is being considered.
The Capital District Health Authority (CDHA) PET/CT program has operated since June, 2008
and to date has examined over 2000 patients utilizing Health Canada approved 18F-FDG
produced by Pharmalogic in Montreal. A significant component of the PET Program
infrastructure in Nova Scotia is the Medical Imaging and Research Centre (MIRC NS) including
a GMP grade radiopharmaceutical production lab and cyclotron. This CTA will allow evaluation
of 18F-FDG produced at the MIRC-NS in a similar case load to prove its clinical utility and
safety.
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Observational Model: Case-Only, Time Perspective: Prospective