18F-fluorodeoxyglucose (18F-FDG) Positron Emission Tomography in Oncology
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| ClinicalTrials.gov Identifier: NCT00207298 |
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Recruitment Status : Unknown
Verified November 2010 by British Columbia Cancer Agency.
Recruitment status was: Recruiting
First Posted : September 21, 2005
Last Update Posted : November 5, 2010
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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 | Phase |
|---|---|---|
| Brain Neoplasms Lung Neoplasms Lymphoma Melanoma Colorectal Neoplasms | Procedure: Positron Emission Tomography | Phase 3 |
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| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 5000 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | June 2005 |
| Study Completion Date : | November 2008 |
- Change in management based on PET procedure
- Sensitivity of PET
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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 |
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).
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
| Contact: Don C Wilson, MD | 604-707-5979 | dowilson@bccancer.bc.ca |
| 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 | |
| Principal Investigator: | Don C Wilson, MD | British Columbia Cancer Agency |
Additional Information:
| Responsible Party: | Dr Don Wilson, British Columbia Cancer Agency |
| ClinicalTrials.gov Identifier: | NCT00207298 History of Changes |
| Other Study ID Numbers: |
R05-0076 |
| First Posted: | September 21, 2005 Key Record Dates |
| Last Update Posted: | November 5, 2010 |
| Last Verified: | November 2010 |
Additional relevant MeSH terms:
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Neoplasms 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 Fluorodeoxyglucose F18 Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |