Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Cancer or Suspected Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00123760
First received: July 22, 2005
Last updated: March 15, 2012
Last verified: March 2012
  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 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase I/II, Phase III and Extended Phase III Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Cancer or Suspected Cancer

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Enrollment: 10838
Study Start Date: February 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  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
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: NCT00123760

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Alexander McEwan, MB, MSc, MD, FRCP AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00123760     History of Changes
Other Study ID Numbers: SP-11-0035/DX-FDG-001/21221
Study First Received: July 22, 2005
Last Updated: March 15, 2012
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Brain Neoplasms
Thyroid 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
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Deoxyglucose
Fluorodeoxyglucose F18
Antimetabolites

ClinicalTrials.gov processed this record on September 18, 2014