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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by British Columbia Cancer Agency.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00207298
First received: September 13, 2005
Last updated: November 3, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Brain Neoplasms
Lung Neoplasms
Lymphoma
Melanoma
Colorectal Neoplasms
Procedure: Positron Emission Tomography
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase III Open Label Trial for Use of [18F]-Fluoro-Deoxy-Glucose (18F-FDG) in Positron Emission Tomography Imaging in Oncology

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Change in management based on PET procedure

Secondary Outcome Measures:
  • Sensitivity of PET

Estimated Enrollment: 5000
Study Start Date: June 2005
Estimated Study Completion Date: November 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be a resident of British Columbia
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207298

Contacts
Contact: Don C Wilson, MD 604-707-5979 dowilson@bccancer.bc.ca

Locations
Canada, British Columbia
BCCA, Vancouver Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Don C Wilson, MD    604-707-5979    dowilson@bccancer.bc.ca   
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Don C Wilson, MD British Columbia Cancer Agency
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Don Wilson, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00207298     History of Changes
Other Study ID Numbers: R05-0076
Study First Received: September 13, 2005
Last Updated: November 3, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Brain Neoplasms
Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Lymphoma
Melanoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Histologic Type
Neuroendocrine Tumors

ClinicalTrials.gov processed this record on August 28, 2014