Registry Type Study to Monitor for Adverse Drug Reactions to Fedoruk Manufactured [F-18]-Fludeoxyglucose

• Status: Completed
• Trial end date: 2017-01-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-centre, open-label, non-randomized clinical trial designed to monitor the occurrence of adverse events associated with [F-18]-FDG Injection manufactured by the Fedoruk Centre. [F-18]-FDG Injection used in this clinical trial will be identical to commercial [F-18]-FDG that is already used at Royal University Hospital (RUH).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Saskatchewan
• Collaborators: Saskatoon Health Region; Sylvia Fedoruk Canadian Centre for Nuclear Innovation
• Treatments: Fluorodeoxyglucose F18

Criteria

Inclusion Criteria:

• Referred by treating physician to receive [F-18]-FDG and PET or PET/CT imaging;

• Meets all current local clinical criteria for receiving [F-18]-FDG and PET or PET/CT imaging;

• Ability to understand and the willingness to sign, or (in the case of paediatric patients) a parent/guardian who understands and is willing to sign, a written informed consent document;

Exclusion Criteria:

• Pregnant women; all women of child-bearing potential will have a confirmed negative urine pregnancy test prior to administration of [F-18]-FDG Injection;

• Subjects unwilling or unable to stop breast feeding for 24 hours;

• Subjects who are medically unstable, based on the Principal Investigator's assessment