Clinical Trial to Evaluate the Safety and Clinical Utility of 18F-FDG Produced by the Molecular Imaging and Research Centre of Nova Scotia
- Conditions
- 18FDG
- Registration Number
- NCT01136720
- Lead Sponsor
- Nova Scotia Health Authority
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 9463
Oncology<br><br> - Diagnosis to determine if a suspicious lesion is cancer<br><br> - Staging of confirmed cancer<br><br> - Evaluation of treatment response<br><br> - Follow up for cancer with high risk of recurrence<br><br> - Restaging following therapy<br><br> - Diagnosis of an unknown primary<br><br> - Assessment of potential paraneoplastic syndrome<br><br> - Radiation therapy planning<br><br>Neurology<br><br>18F-FDG PET will be used for evaluation of patients with<br><br> - Dementia, for differential diagnosis and prognosis<br><br> - Mild cognitive impairment, for suspected dementia<br><br> - Epilepsy, for localization of a seizure focus<br><br>Cardiology<br><br>• 18F-FDG PET in the evaluation of patients with ischemic heart disease and severely<br>compromised myocardial function to aid in the evaluation of the appropriateness of<br>revascularization.<br><br>General inclusion criteria:<br><br> - Diabetic patients are admissible, but will require proper control of their glucose<br> levels (below 14) if possible prior to the scan.<br><br> - Receipt of an acceptably completed PET/CT scan requisition will be necessary.<br><br> - Patients will be able to tolerate the physical and logistic requirements of<br> completing a PET scan including weight below 450lb and not claustrophobic to the<br> extent that they can't tolerate being in the scanner gantry<br><br>EXCLUSION CRITERIA<br><br> - Pregnant women; if there is any possibility of pregnancy, a blood HCG level will be<br> obtained<br><br> - Patients unwilling or unable to stop breast feeding for 24 hours<br><br> - Patients or guardians unwilling or unable to provide informed consent<br><br> - Patients who are medically unstable<br><br> - Patients who exceed the safe weight limit of the PET/CT bed or who cannot fit<br> through the PET/CT gantry
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ensure the Safety profile of the Halifax produced FDG is similar to litature based findings
- Secondary Outcome Measures
Name Time Method To effectively demonstrate diagnostic performance of the Halifax produced FDS in patients with focal lung pathology mirroring that previously published