18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology
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ClinicalTrials.gov Identifier: NCT01180751 |
Recruitment Status : Unknown
Verified July 2013 by University of Manitoba.
Recruitment status was: Enrolling by invitation
First Posted : August 12, 2010
Last Update Posted : August 15, 2013
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Condition or disease | Intervention/treatment | Phase |
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Tumors | Radiation: [18F]-Fluorodeoxyglucose | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | 18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | June 2013 |
Estimated Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
[18F]-Fluorodeoxyglucose
Scanning Procedure: Non-diagnostic Computed Tomography (CT) scan followed by a Diagnostic Positron Emission Tomography (PET) scan.
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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.
Other Name: FDG (18F-Fluorodeoxyglucose) |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180751
Canada, Manitoba | |
Great West Life PET/CT Centre | |
Winnipeg, Manitoba, Canada, R3E 3P4 |
Principal Investigator: | Daniel P Levin, BSc,MD,FRCPC | Winnipeg Regional Health Authority |
Responsible Party: | Dr. Daniel Levin, Winnipeg Regional Health Authority |
ClinicalTrials.gov Identifier: | NCT01180751 |
Other Study ID Numbers: |
B2010:014 |
First Posted: | August 12, 2010 Key Record Dates |
Last Update Posted: | August 15, 2013 |
Last Verified: | July 2013 |
Positron Emission Tomography Fluorodeoxyglucose FDG (18F-Fluorodeoxyglucose) Oncology Neurology |
Neoplasms Fluorodeoxyglucose F18 Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |