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Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Cancer or Suspected Cancer
This study is currently recruiting participants.
Verified by Alberta Cancer Board, November 2007
Sponsored by: Alberta Cancer Board
Information provided by: Alberta Cancer Board
ClinicalTrials.gov Identifier: NCT00123760
  Purpose

Positron Emission Tomography (PET) is a specialised nuclear medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity. The most common of these radiolabeled tracers is 18F-fluorodeoxyglucose (18F-FDG), which is used to determine abnormal glucose metabolism in tumours and other sites. It has general applications in all areas where abnormal glucose metabolism may be present including in circumstances such as differentiating the tumour from scar tissue; evaluating the presence of the tumour in light of rising tumour markers and normal morphological imaging techniques; and assessing response to therapy where other techniques are deemed to be unhelpful. The Cross Cancer Institute (CCI) has recently been funded to establish a PET centre, and this study will prove the effectiveness of PET scanning in the Canadian health care environment and validate the data that have been developed in other jurisdictions in specific oncologic indications.


Condition Intervention Phase
Brain Neoplasms
Lung Neoplasms
Thyroid Neoplasms
Colorectal Neoplasms
Lymphoma
Procedure: Positron Emission Tomography (PET) scan
Phase II
Phase III

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors Colorectal Cancer Lung Cancer Lymphoma Nuclear Scans Thyroid Cancer
Drug Information available for: Fluorodeoxyglucose F18 X-Rays
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Phase I/II, Phase III and Extended Phase III Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Cancer or Suspected Cancer

Further study details as provided by Alberta Cancer Board:

Primary Outcome Measures:
  • To demonstrate the safety of 18F-FDG synthesized from cyclotron produced radiofluoride in the Coincidence Technologies automated synthesis unit (ASU) in the Edmonton PET Centre facility [ Time Frame: One Year ]

Secondary Outcome Measures:
  • To confirm the diagnostic effectiveness of 18F-FDG in subjects with known or suspected oncologic disease and compare this to literature values [ Time Frame: One Year ]

Estimated Enrollment: 3500
Study Start Date: February 2004
Estimated Study Completion Date: July 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female. (If female of child-bearing potential and outside of the window of 10 days since the last menstrual period, a negative serum or urine pregnancy test is required.)
  • Known or suspected primary or metastatic tumours
  • Age equal to or greater than 15 years
  • Able and willing to follow instructions and comply with the protocol
  • Provide written informed consent prior to participation in this study
  • Karnofsky Performance Scale score 60-100

Exclusion Criteria:

  • Nursing or pregnant females
  • Presence of a severe infection
  • Age less than 15 years
  • Having had surgery or radiotherapy within 10 days of the planned imaging study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123760

Contacts
Contact: Alexander McEwan, MB, MSc, MD, FRCP 780-432-8524 sandymce@cancerboard.ab.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Clinical Research Unit     780-989-8152     clinical_trials_cci@cancerboard.ab.ca    
Principal Investigator: Alexander McEwan, MB, MSc, MD, FRCP            
Sponsors and Collaborators
Alberta Cancer Board
Investigators
Principal Investigator: Alexander McEwan, MB, MSc, MD, FRCP Alberta Cancer Board
  More Information

Study ID Numbers: SP-11-0035
Study First Received: July 22, 2005
Last Updated: September 22, 2008
ClinicalTrials.gov Identifier: NCT00123760  
Health Authority: Canada: Health Canada

Keywords provided by Alberta Cancer Board:
Positron-Emission Tomography
Fluorodeoxyglucose F18
Tomography scanners, X-Ray computed

Study placed in the following topic categories:
Thoracic Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Central Nervous System Neoplasms
Brain Diseases
Rectal Diseases
Respiratory Tract Diseases
Lung Neoplasms
Lymphoma
Thyroid Diseases
Nervous System Neoplasms
Endocrine Gland Neoplasms
Immunoproliferative Disorders
Digestive System Neoplasms
Thyroid Neoplasms
Endocrine System Diseases
Central Nervous System Diseases
Intestinal Diseases
Intestinal Neoplasms
Lymphatic Diseases
Brain Neoplasms
Digestive System Diseases
Head and Neck Neoplasms
Lung Diseases
Deoxyglucose
Gastrointestinal Neoplasms
Endocrinopathy
Lymphoproliferative Disorders
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Nervous System Diseases
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009