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

University of Saskatchewan0 sites1,012 target enrollmentJune 2016

ConditionsPositron-Emission Tomography and Cone-Beam Computed Tomography

Interventions[F-18]-Fludeoxyglucose

Drugs[F-18]-Fludeoxyglucose

Overview

Phase: Phase 4
Intervention: [F-18]-Fludeoxyglucose
Conditions: Positron-Emission Tomography and Cone-Beam Computed Tomography
Sponsor: University of Saskatchewan
Enrollment: 1012
Primary Endpoint: Document any adverse drug reactions, following administration of [F-18]-FDG Injection.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

January 30, 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Saskatchewan

Responsible Party

Principal Investigator

Paul Babyn

M.D.

University of Saskatchewan

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