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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02811185

Enrollment

1012

Registered

2016-06-23

Start date

2016-06-30

Completion date

2017-01-30

Last updated

2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Positron-Emission Tomography and Cone-Beam Computed Tomography

Keywords

PET, CT, PET/CT

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.

Interventions

DRUG[F-18]-Fludeoxyglucose

Radiopharmaceutical imaging agent

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026