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

Phase 4

Completed

• Conditions: Positron-Emission Tomography and Cone-Beam Computed Tomography
• Interventions: Drug: [F-18]-Fludeoxyglucose

• Registration Number: NCT02811185
• Lead Sponsor: University of Saskatchewan

Brief 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-23
• Primary Completion: 2017-01
• Study Completion: 2017-01-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1012

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/CT Scan	[F-18]-Fludeoxyglucose	Subjects will receive a single dose of \[F-18\]-FDG Injection at Visit 1, followed by PET/CT scanning according to departmental practice.
PET Scan	[F-18]-Fludeoxyglucose	Subjects will receive a single dose of \[F-18\]-FDG Injection at Visit 1, followed by PET scanning according to departmental practice.

Primary Outcome Measures

Name	Time	Method
Document any adverse drug reactions, following administration of [F-18]-FDG Injection.	1 day