- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01180751
18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology
August 14, 2013 updated by: University of Manitoba
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
- Great West Life PET/CT Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: [18F]-Fluorodeoxyglucose
Scanning Procedure: Non-diagnostic Computed Tomography (CT) scan followed by a Diagnostic Positron Emission Tomography (PET) scan.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To confirm the diagnostic effectiveness of 18F-Fluorodeoxyglucose(FDG) as compared to the gold standard of histopathological diagnosis.
Time Frame: Three years
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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.
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Three years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel P Levin, BSc,MD,FRCPC, Winnipeg Regional Health Authority
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
June 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
August 11, 2010
First Submitted That Met QC Criteria
August 11, 2010
First Posted (Estimate)
August 12, 2010
Study Record Updates
Last Update Posted (Estimate)
August 15, 2013
Last Update Submitted That Met QC Criteria
August 14, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2010:014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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