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

NCT00207298 | Completed

• 1 other identifier: R05-0076
• Study Type: observational
• Target: 39,242
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasms; Lung Neoplasms; Lymphoma; Melanoma; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Change in management based on PET procedure

  Up to 6 weeks

Secondary Outcomes (2)

• Sensitivity of PET

  Up to 6 weeks

• Safety of 18F-FDG

  Up to 24 hours after completion of PET scan

Interventions

Positron Emission Tomography PROCEDURE

Each patient will receive an 18F-FDG PET/CT scan

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Oncology patients in British Columbia who meet the eligibility requirements.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BCCA, Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Links

• British Columbia Cancer Agency website

MeSH Terms

Conditions

Brain Neoplasms; Lung Neoplasms; Lymphoma; Melanoma; Colorectal Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Don C Wilson, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: June 1, 2005
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 10, 2019

Record last verified: 2018-12

Locations

CA (1)