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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Positron-Emission Tomography and Cone-Beam Computed Tomography

Intervention / Treatment
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* Drug: [F-18]-Fludeoxyglucose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PET/CT Scan<br>Subjects will receive a single dose of [F-18]-FDG Injection at Visit 1, followed by PET/CT scanning according to departmental practice. | Drug: [F-18]-Fludeoxyglucose<br>* Radiopharmaceutical imaging agent<br>* Other names: F-18-FDG;|
| Other: PET Scan<br>Subjects will receive a single dose of [F-18]-FDG Injection at Visit 1, followed by PET scanning according to departmental practice. | Drug: [F-18]-Fludeoxyglucose<br>* Radiopharmaceutical imaging agent<br>* Other names: F-18-FDG;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET, CT, PET/CT