Clinical trial NCT02811185: Registry Type Study to Monitor for Adverse Drug Reactions to Fedoruk Manufactured [F-18]-Fludeoxyglucose
Official title: An Open-label, Non-randomized Study to Monitor for Adverse Drug Reactions Among Patients Administered Fedoruk-manufactured [F-18]-FDG Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Positron-Emission Tomography and Cone-Beam Computed Tomography
Keywords: PET
CT
PET/CT
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Sylvia Fedoruk Canadian Centre for Nuclear Innovation
name: Saskatoon Health Region
First posted: 2016-06-23
Enrollment: 1012
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Document any adverse drug reactions, following administration of [F-18]-FDG Injection.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Saskatoon Health Region
name: Rajan Rakheja, MD
role: PRINCIPAL_INVESTIGATOR
References: