18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Tumors
- Sponsor
- University of Manitoba
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- To confirm the diagnostic effectiveness of 18F-Fluorodeoxyglucose(FDG) as compared to the gold standard of histopathological diagnosis.
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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.