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

May 1, 2017 updated by: Paul Babyn, University of Saskatchewan

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1012

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Collaborators

Saskatoon Health Region
Sylvia Fedoruk Canadian Centre for Nuclear Innovation

Investigators

  • Principal Investigator: Rajan Rakheja, MD, Saskatoon Health Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 30, 2017

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FED001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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