NCT02811185

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,012 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Positron-Emission Tomography and Cone-Beam Computed Tomography

Interventions

Type	Name	Description
DRUG	[F-18]-Fludeoxyglucose	Radiopharmaceutical imaging agent

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-01-01
• Completion: 2017-01-30
• First posted: 2016-06-23
• Last updated: 2017-05-04