18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

Tumors Clinical Trial

Official title:

18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01180751
• Other study ID #: B2010:014
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: August 11, 2010
• Last updated: August 14, 2013
• Start date: July 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2013
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Tumors

Intervention

Radiation:
• [18F]-Fluorodeoxyglucose
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.

Locations

Country	Name	City	State
Canada	Great West Life PET/CT Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Winnipeg Regional Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No