Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Cancer or Suspected Cancer
This study has been completed.
Sponsor:
Alberta Health Services
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00123760
First received: July 22, 2005
Last updated: March 15, 2012
Last verified: March 2012
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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:
MedlinePlus related topics:
Brain Cancer
Cancer
Childhood Brain Tumors
Colorectal Cancer
Lung Cancer
Lymphoma
Nuclear Scans
Thyroid Cancer
Thyroid Diseases
Drug Information available for:
Fludeoxyglucose F 18
U.S. FDA Resources
Further study details as provided by Alberta Health Services:
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
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
Alberta Health Services
Investigators
| Principal Investigator: | Alexander McEwan, MB, MSc, MD, FRCP | Alberta Health Services |
More Information
Additional Information:
No publications provided
| Responsible Party: | Alberta Health Services |
| 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 Alberta Health Services:
|
Positron-Emission Tomography Fluorodeoxyglucose F18 Tomography scanners, X-Ray computed |
Additional relevant MeSH terms:
|
Brain Neoplasms Neoplasms Thyroid Neoplasms Colorectal Neoplasms Lung Neoplasms Lymphoma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine Gland Neoplasms Head and Neck Neoplasms Endocrine System Diseases |
Thyroid Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders |
ClinicalTrials.gov processed this record on June 18, 2013