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.
| Status | Recruiting |
| Enrollment | 3000 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year and older |
| Eligibility |
Oncology - Diagnosis to determine if a suspicious lesion is cancer - Staging of confirmed cancer - Evaluation of treatment response - Follow up for cancer with high risk of recurrence - Restaging following therapy - Diagnosis of an unknown primary - Assessment of potential paraneoplastic syndrome - Radiation therapy planning Neurology 18F-FDG PET will be used for evaluation of patients with - Dementia, for differential diagnosis and prognosis - Mild cognitive impairment, for suspected dementia - Epilepsy, for localization of a seizure focus Cardiology • 18F-FDG PET in the evaluation of patients with ischemic heart disease and severely compromised myocardial function to aid in the evaluation of the appropriateness of revascularization. General inclusion criteria: - Diabetic patients are admissible, but will require proper control of their glucose levels (below 14) if possible prior to the scan. - Receipt of an acceptably completed PET/CT scan requisition will be necessary. - Patients will be able to tolerate the physical and logistic requirements of completing a PET scan including weight below 450lb and not claustrophobic to the extent that they can't tolerate being in the scanner gantry EXCLUSION CRITERIA - Pregnant women; if there is any possibility of pregnancy, a blood HCG level will be obtained - Patients unwilling or unable to stop breast feeding for 24 hours - Patients or guardians unwilling or unable to provide informed consent - Patients who are medically unstable - Patients who exceed the safe weight limit of the PET/CT bed or who cannot fit through the PET/CT gantry |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Canada | CapitalDHACanada | Halifax | Nova Scotia |
| Lead Sponsor | Collaborator |
|---|---|
| Nova Scotia Health Authority |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ensure the Safety profile of the Halifax produced FDG is similar to litature based findings | 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 | 3 hours post injection | Yes |
| Secondary | To effectively demonstrate diagnostic performance of the Halifax produced FDS in patients with focal lung pathology mirroring that previously published | 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. | 6 months | No |