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18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

Phase 3
18 Years
Open (Enrolling by invite only)

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Trial Information

18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Three years

Safety Issue:


Principal Investigator

Daniel P Levin, BSc,MD,FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Winnipeg Regional Health Authority


Canada: Health Canada

Study ID:




Start Date:

July 2010

Completion Date:

April 2013

Related Keywords:

  • Tumors
  • Positron Emission Tomography
  • Fluorodeoxyglucose
  • FDG
  • Oncology
  • Neurology