18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

Phase 3

• Conditions: Tumors
• Interventions: Radiation: [18F]-Fluorodeoxyglucose

• Registration Number: NCT01180751
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Primary Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-08-14
• Last Update Posted: 2013-08-15
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]-Fluorodeoxyglucose	[18F]-Fluorodeoxyglucose	Scanning Procedure: Non-diagnostic Computed Tomography (CT) scan followed by a Diagnostic Positron Emission Tomography (PET) scan.

Primary Outcome Measures

Name	Time	Method
To confirm the diagnostic effectiveness of 18F-Fluorodeoxyglucose(FDG) as compared to the gold standard of histopathological diagnosis.	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.

Trial Locations

Locations (1)

Great West Life PET/CT Centre; 🇨🇦 Winnipeg, Manitoba, Canada