Clinical Trial to Evaluate the Safety and Clinical Utility of 18F-FDG Produced by the Molecular Imaging and Research Centre of Nova Scotia
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Clinical Trial to Evaluate the Safety and Clinical Utility of18F-FDG Produced by the Molecular Imaging and Research Centre of Nova Scotia|
- Ensure the Safety profile of the Halifax produced FDG is similar to litature based findings [ Time Frame: 3 hours post injection ] [ Designated as safety issue: Yes ]The safety profile of the radiopharmaceutical will be monitored for adverse affects during the time in the department following injection. The technologists will inquire and note any potential signs or symptoms of adverse reactions. At the conclusion of the PET Centre visit, the patient will fill out a questionnaire assessing any potential adverse effects
- To effectively demonstrate diagnostic performance of the Halifax produced FDS in patients with focal lung pathology mirroring that previously published [ Time Frame: 6 months ] [ Designated as safety issue: No ]The clinical efficacy will be analyzed in the patients with focal lung pathology. The clinical course of these patients will be followed to determine the true nature of these focal lesions with the gold standard being pathologic evaluation from either surgical procedure or biopsy results. In patients whom pathology is not made available, assessment of the lesion nature will be determined by other clinical indicators in consultation with the managing physicians opinion based upon these factors and the patient's clinical course.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|patients injected with the Halifax produced 18-FDG|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136720
|Contact: Andrew Ross, MD FRCPfirstname.lastname@example.org|
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada, B3H1Y5|