Status:
COMPLETED
Clinical Trial to Evaluate the Safety and Clinical Utility of 18F-FDG Produced by the Molecular Imaging and Research Centre of Nova Scotia
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
18FDG
Eligibility:
All Genders
1+ years
Brief Summary
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...
Detailed Description
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 ....
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 19 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 18 2017
Estimated Enrollment :
9463 Patients enrolled
Trial Details
Trial ID
NCT01136720
Start Date
June 19 2010
End Date
April 18 2017
Last Update
August 21 2024
Active Locations (1)
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1
CapitalDHACanada
Halifax, Nova Scotia, Canada, B3H1Y5