NCT02811185

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,012

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

June 15, 2016

Last Update Submit

May 1, 2017

Conditions

Positron-Emission Tomography and Cone-Beam Computed Tomography

Keywords

PETCTPET/CT

Outcome Measures

Primary Outcomes (1)

  • Document any adverse drug reactions, following administration of [F-18]-FDG Injection.

    1 day

Study Arms (2)

PET/CT Scan

OTHER

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

PET Scan

OTHER

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

Interventions

[F-18]-FludeoxyglucoseDRUG

Radiopharmaceutical imaging agent

Also known as: FDG, Fluorodeoxyglucose, F-18-FDG
PET ScanPET/CT Scan

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Rajan Rakheja, MD

    Saskatoon Health Region

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 23, 2016

Study Start

June 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 30, 2017

Last Updated

May 4, 2017

Record last verified: 2017-05