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

An Open-label, Non-randomized Study to Monitor for Adverse Drug Reactions Among Patients Administered Fedoruk-manufactured [F-18]-FDG Injection

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).

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]-FDG Injection. Eligible subjects are those who would normally be referred by their physician for [F-18]-FDG PET or PET/CT imaging at RUH in Saskatoon, SK.

The primary goal of this study is to permit immediate access, with appropriate regulatory and REB oversight, to Fedoruk-manufactured [F-18]-FDG Injection pending commercial approval.

Monitoring for adverse drug reactions, during and after subjects are administered Fedoruk-manufactured [F-18]-FDG Injection, will support the primary objective of this study. Based on the well-established safety profile of [F-18]-FDG and the comparability of Fedoruk-manufactured [F-18]-FDG Injection to commercially-approved [F-18]-FDG Injection (Glucovision®), it is not expected that any ADRs will be observed.

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