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

Launched by UNIVERSITY OF SASKATCHEWAN · Jun 20, 2016

Keywords

ClinConnect Summary

This study will document the use of Fedoruk-manufactured \[F-18\]-FDG Injection (citrate formulation) in patients referred for \[F-18\]-FDG PET or PET/CT imaging at Royal University Hospital (RUH) in Saskatoon, SK. This investigational agent is produced using procedures, raw materials, equipment and quality standards that are equivalent to commercially-approved \[F-18\]-FDG Injection (Glucovision®, manufactured by the CPDC in Hamilton ON).

This is a single-centre, open-label, non-randomized study to monitor for adverse drug reactions among subjects administered Fedoruk-manufactured \[F-18\...

Gender

ALL

Eligibility 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