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18F-fluorodeoxyglucose (18F-FDG) Positron Emission Tomography in Oncology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00207298
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 10, 2019
Information provided by (Responsible Party):
British Columbia Cancer Agency

Brief Summary:

Positron emission tomography (PET) is a nuclear medicine procedure based on the measurement of positron emission from radiolabelled tracer molecules. These radiotracers allow biologic processes to be measured and whole body images to be obtained which demonstrates sites of radiotracer accumulation. The most common radiotracer in use today is 18F-fluorodeoxyglucose (18F-FDG) which is a radiolabelled sugar (glucose) molecule. Imaging with 18F-FDG PET is used to determine sites of abnormal glucose metabolism and can be used to characterize and localize many types of tumours.

Cancer treatment and outcome depend largely on the accurate diagnosis and staging of disease. There is extensive data in the literature indicating the importance of FDG-PET imaging in accurately characterizing disease, as well as determining stage and sites of recurrent disease in many cancer types. For these indications, functional imaging with PET provides unique information which is not available from standard medical imaging modalities such as ultrasound, X-ray, computerized tomography (CT) or magnetic resonance imaging (MRI).

The objectives of this study are to document the safety and efficacy of 18F-FDG produced by the British Columbia Cancer Agency (BCCA) at its Tri-University Meson Facility (TRIUMF) production facility and to evaluate FDG-PET as a diagnostic and decision making tool in the management of oncology patients in British Columbia. With a population base of over 4 million people, standardized cancer treatment protocols, and evidence based guidelines for FDG-PET imaging, the BCCA is positioned to make an important contribution to defining the role of PET in the Canadian health care system.

Condition or disease Intervention/treatment
Brain Neoplasms Lung Neoplasms Lymphoma Melanoma Colorectal Neoplasms Procedure: Positron Emission Tomography

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Study Type : Observational
Actual Enrollment : 39242 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase III Open Label Trial for Use of [18F]-Fluoro-Deoxy-Glucose (18F-FDG) in Positron Emission Tomography Imaging in Oncology
Study Start Date : June 2005
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Positron Emission Tomography
    Each patient will receive an 18F-FDG PET/CT scan

Primary Outcome Measures :
  1. Change in management based on PET procedure [ Time Frame: Up to 6 weeks ]

Secondary Outcome Measures :
  1. Sensitivity of PET [ Time Frame: Up to 6 weeks ]
  2. Safety of 18F-FDG [ Time Frame: Up to 24 hours after completion of PET scan ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Oncology patients in British Columbia who meet the eligibility requirements.

Inclusion Criteria:

  • Age 19 years or older.
  • ECOG performance status 0 - 3.
  • Able to provide written informed consent.
  • Referred by a treating physician.
  • Must meet BCCA evidence-based guidelines for FDG-PET in oncology
  • Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 45 minutes and tolerating intravenous cannulation for injection.

Exclusion Criteria:

  • Patients' blood glucose > 11.1 mmol/L (200 mg/dL) measured by glucometer immediately prior to scan.
  • Pregnancy
  • Patients unable to provide informed consent.
  • Patients who are medically unstable e.g. acute cardiac or respiratory distress or hypotensive
  • Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70 cm).

Information from the National Library of Medicine

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): NCT00207298

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Canada, British Columbia
BCCA, Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
British Columbia Cancer Agency
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Principal Investigator: Don C Wilson, MD British Columbia Cancer Agency
Additional Information:
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Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00207298    
Other Study ID Numbers: R05-0076
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Lung Neoplasms
Brain Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases