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18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Winnipeg Regional Health Authority
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01180751
First received: August 11, 2010
Last updated: July 26, 2012
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Tumors
 Radiation: [18F]-Fluorodeoxyglucose
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • To confirm the diagnostic effectiveness of 18F-Fluorodeoxyglucose(FDG) as compared to the gold standard of histopathological diagnosis. [ Time Frame: Three years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1000
Study Start Date: July 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
[18F]-Fluorodeoxyglucose
Scanning Procedure: Non-diagnostic Computed Tomography (CT) scan followed by a Diagnostic Positron Emission Tomography (PET) scan.
 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.
Other Name: FDG

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180751

Locations
Canada, Manitoba
Great West Life PET/CT Centre
Winnipeg, Manitoba, Canada, R3E 3P4
Sponsors and Collaborators
University of Manitoba
Winnipeg Regional Health Authority
Investigators
Principal Investigator: Daniel P Levin, BSc,MD,FRCPC Winnipeg Regional Health Authority
  More Information

No publications provided

Responsible Party: Dr. Daniel Levin, Winnipeg Regional Health Authority
ClinicalTrials.gov Identifier: NCT01180751     History of Changes
Other Study ID Numbers: B2010:014
Study First Received: August 11, 2010
Last Updated: July 26, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Positron Emission Tomography
Fluorodeoxyglucose
FDG
Oncology
Neurology

Additional relevant MeSH terms:
Deoxyglucose
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013