18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

NCT01180751 | Unknown Phase 3 DMC

• 1 other identifier: B2010:014
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumors

Keywords

Positron Emission Tomography; Fluorodeoxyglucose; FDG (18F-Fluorodeoxyglucose); Oncology; Neurology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

[18F]-Fluorodeoxyglucose

OTHER

Scanning Procedure: Non-diagnostic Computed Tomography (CT) scan followed by a Diagnostic Positron Emission Tomography (PET) scan.

Radiation: [18F]-Fluorodeoxyglucose

Interventions

[18F]-Fluorodeoxyglucose RADIATION

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.

Also known as: FDG (18F-Fluorodeoxyglucose)

[18F]-Fluorodeoxyglucose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known or suspected primary or metastatic tumours
• A neurological presentation consistent with the list of indications
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Winnipeg Regional Health Authority: collaborator

Study Sites (1)

Great West Life PET/CT Centre

Winnipeg, Manitoba, R3E 3P4, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Daniel P Levin, BSc,MD,FRCPC

  Winnipeg Regional Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 12, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 15, 2013

Record last verified: 2013-07

Locations

CA (1)