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Status unknownNCT01180751Updated Aug 15, 2013

18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

A Phase 3 interventional study of [18F]-Fluorodeoxyglucose in Tumors, sponsored by University of Manitoba. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-15.

Sponsored by University of Manitoba · Phase 3, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This clinical trial is being conducted to study the use of a radioactive glucose tracer as an imaging test [Positron Emission Tomography (PET)scan] in adults who have or are suspected of having cancer and in another group of adults to assess for neurologic conditions.

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Conditions studied

  • Tumors

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Keywords

  • Positron Emission Tomography
  • Fluorodeoxyglucose
  • FDG (18F-Fluorodeoxyglucose)
  • Oncology
  • Neurology
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Known or suspected primary or metastatic tumours
  • A neurological presentation consistent with the list of indications
  • 18 years of age or older of either sex
  • Able to provide written informed consent
  • Able to tolerate the physical and logistical requirements of completing a Positron Emission Tomography (PET)scan
  • Karnofsky score > 60
  • Women who are nursing may be included in the study if they are able to discontinue breast feeding for 12 hours

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years
  • Pregnant women; if there is a possibility of pregnancy, bloodwork will be drawn to definitively establish pregnancy status
  • Women who are unwilling or unable to discontinue breast feeding for 12 hours post 18F-Fluorodeoxyglucose(FDG) administration
  • Subjects who are medically unstable
  • Subjects unwilling to provide informed consent.
  • Subjects who exceed the safe weight limit of the Positron Emission Tomography (PET) imaging bed or who cannot fit through the PET scanner bore
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Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Other
    [18F]-Fluorodeoxyglucose

    Scanning Procedure: Non-diagnostic Computed Tomography (CT) scan followed by a Diagnostic Positron Emission Tomography (PET) scan.

    Radiation: [18F]-Fluorodeoxyglucose

Interventions

  • Radiation[18F]-Fluorodeoxyglucose

    With each Positron Emission Tomography/Computed Tomography (PET/CT)scan an intravenous administration of radioactive glucose (FDG)is given. This is a weight dependent dosage.

    Also known as: FDG (18F-Fluorodeoxyglucose)

06

What researchers measure

Primary outcomes

  1. To confirm the diagnostic effectiveness of 18F-Fluorodeoxyglucose(FDG) as compared to the gold standard of histopathological diagnosis.

    The primary outcomes of sensitivity and accuracy of 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) studies will be obtained by comparing results of the PET scan with the gold standard of histopathological diagnosis when those results are available. Comparison to correlative imaging follow-up, and assessment of efficacy based on feedback from referring physicians will be used in the absence of pathologic data.

    Time frame: Three years

07

Study locations

1 site
  • Great West Life PET/CT Centre
    Winnipeg, Manitoba R3E 3P4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01180751
Lead sponsor
University of Manitoba
Collaborators
Winnipeg Regional Health Authority
First posted
Aug 12, 2010
Start date
Jul 2010
Primary completion
Jun 2013
Completion
Dec 2013 (estimated)
Last update
Aug 15, 2013

Study contacts

Daniel P Levin, BSc,MD,FRCPC
principal investigator · Winnipeg Regional Health Authority

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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