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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

August 11, 2010
July 26, 2012
July 2010
April 2013   (final data collection date for primary outcome measure)
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.
To confirm the diagnostic effectiveness of 18F-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-FDG 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.
Complete list of historical versions of study NCT01180751 on ClinicalTrials.gov Archive Site
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18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology
18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Tumors
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
Scanning Procedure: Non-diagnostic Computed Tomography (CT) scan followed by a Diagnostic Positron Emission Tomography (PET) scan.
Intervention: Radiation: [18F]-Fluorodeoxyglucose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1000
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01180751
B2010:014
Yes
Dr. Daniel Levin, Winnipeg Regional Health Authority
University of Manitoba
Winnipeg Regional Health Authority
Principal Investigator: Daniel P Levin, BSc,MD,FRCPC Winnipeg Regional Health Authority
University of Manitoba
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP