Registry Type Study to Monitor for Adverse Drug Reactions to Fedoruk Manufactured [F-18]-Fludeoxyglucose
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ClinicalTrials.gov Identifier: NCT02811185 |
Recruitment Status :
Completed
First Posted : June 23, 2016
Last Update Posted : May 4, 2017
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Condition or disease | Intervention/treatment | Phase |
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Positron-Emission Tomography and Cone-Beam Computed Tomography | Drug: [F-18]-Fludeoxyglucose | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1012 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | An Open-label, Non-randomized Study to Monitor for Adverse Drug Reactions Among Patients Administered Fedoruk-manufactured [F-18]-FDG Injection |
Study Start Date : | June 2016 |
Actual Primary Completion Date : | January 2017 |
Actual Study Completion Date : | January 30, 2017 |

Arm | Intervention/treatment |
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PET/CT Scan
Subjects will receive a single dose of [F-18]-FDG Injection at Visit 1, followed by PET/CT scanning according to departmental practice.
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Drug: [F-18]-Fludeoxyglucose
Radiopharmaceutical imaging agent
Other Names:
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PET Scan
Subjects will receive a single dose of [F-18]-FDG Injection at Visit 1, followed by PET scanning according to departmental practice.
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Drug: [F-18]-Fludeoxyglucose
Radiopharmaceutical imaging agent
Other Names:
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- Document any adverse drug reactions, following administration of [F-18]-FDG Injection. [ Time Frame: 1 day ]

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Ages Eligible for Study: | 1 Year and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811185
Principal Investigator: | Rajan Rakheja, MD | Saskatoon Health Region |
Responsible Party: | Paul Babyn, M.D., University of Saskatchewan |
ClinicalTrials.gov Identifier: | NCT02811185 |
Other Study ID Numbers: |
FED001 |
First Posted: | June 23, 2016 Key Record Dates |
Last Update Posted: | May 4, 2017 |
Last Verified: | May 2017 |
PET CT PET/CT |
Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders Fluorodeoxyglucose F18 Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |