Clinical Trial to Evaluate the Safety and Clinical Utility of 18F-FDG Produced by the Molecular Imaging and Research Centre of Nova Scotia

NCT01136720 | Completed

• 1 other identifier: 2011-035
• Study Type: observational
• Target: 9,463
• Locations: 1 country
• Sites: 1

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 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.

Conditions

18FDG

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To effectively demonstrate diagnostic performance of the Halifax produced FDS in patients with focal lung pathology mirroring that previously published

  6 months

Study Arms (1)

patients injected with the Halifax produced 18-FDG

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The recruited subjects will be patients referred by medical and surgical specialists involved in cancer management dementia epilepsy and cardiology

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

CapitalDHACanada

Halifax, Nova Scotia, B3H1Y5, Canada

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: June 19, 2010
• Primary Completion: April 18, 2017
• Study Completion: April 18, 2017
• Last Updated: August 21, 2024

Record last verified: 2022-10

Locations

CA (1)