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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
Sponsor:
Collaborators:
Sylvia Fedoruk Canadian Centre for Nuclear Innovation
Saskatoon Health Region
Information provided by (Responsible Party):
Paul Babyn, University of Saskatchewan

Study Description
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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).

Condition or disease Intervention/treatment Phase
Positron-Emission Tomography and Cone-Beam Computed Tomography Drug: [F-18]-Fludeoxyglucose Phase 4

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.

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: [F-18]-Fludeoxyglucose
Radiopharmaceutical imaging agent
Other Names:
  • FDG
  • Fluorodeoxyglucose
  • F-18-FDG
PET Scan
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
Radiopharmaceutical imaging agent
Other Names:
  • FDG
  • Fluorodeoxyglucose
  • F-18-FDG


Outcome Measures
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Primary Outcome Measures :
  1. Document any adverse drug reactions, following administration of [F-18]-FDG Injection. [ Time Frame: 1 day ]

Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Saskatchewan
Sylvia Fedoruk Canadian Centre for Nuclear Innovation
Saskatoon Health Region
Investigators
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Principal Investigator: Rajan Rakheja, MD Saskatoon Health Region
More Information
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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
Keywords provided by Paul Babyn, University of Saskatchewan:
PET
CT
PET/CT
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action