18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

Study Overview
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Brief Summary
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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.

Official Title
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18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

Conditions
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Tumors

Intervention / Treatment
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* Radiation: [18F]-Fluorodeoxyglucose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: [18F]-Fluorodeoxyglucose<br>Scanning Procedure: Non-diagnostic Computed Tomography (CT) scan followed by a Diagnostic Positron Emission Tomography (PET) scan. | Radiation: [18F]-Fluorodeoxyglucose<br>* 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.<br>* Other names: FDG (18F-Fluorodeoxyglucose);|

What is the study measuring?
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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. | 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. | Three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron Emission Tomography, Fluorodeoxyglucose, FDG (18F-Fluorodeoxyglucose), Oncology, Neurology