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18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

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ClinicalTrials.gov Identifier: NCT01180751
Recruitment Status : Unknown
Verified July 2013 by University of Manitoba.
Recruitment status was:  Enrolling by invitation
First Posted : August 12, 2010
Last Update Posted : August 15, 2013
Sponsor:
Collaborator:
Winnipeg Regional Health Authority
Information provided by:
University of Manitoba

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Tumors Radiation: [18F]-Fluorodeoxyglucose Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology
Study Start Date : July 2010
Actual Primary Completion Date : June 2013
Estimated Study Completion Date : December 2013

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Arms and Interventions
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Arm Intervention/treatment
[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 (18F-Fluorodeoxyglucose)


Outcome Measures
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Primary Outcome Measures :
  1. To confirm the diagnostic effectiveness of 18F-Fluorodeoxyglucose(FDG) as compared to the gold standard of histopathological diagnosis. [ Time Frame: Three years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01180751


Locations
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Canada, Manitoba
Great West Life PET/CT Centre
Winnipeg, Manitoba, Canada, R3E 3P4
Sponsors and Collaborators
University of Manitoba
Winnipeg Regional Health Authority
Investigators
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Principal Investigator: Daniel P Levin, BSc,MD,FRCPC Winnipeg Regional Health Authority
More Information
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Responsible Party: Dr. Daniel Levin, Winnipeg Regional Health Authority
ClinicalTrials.gov Identifier: NCT01180751    
Other Study ID Numbers: B2010:014
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: July 2013
Keywords provided by University of Manitoba:
Positron Emission Tomography
Fluorodeoxyglucose
FDG (18F-Fluorodeoxyglucose)
Oncology
Neurology
Additional relevant MeSH terms:
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Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action