Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Cancer or Suspected Cancer
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ClinicalTrials.gov Identifier: NCT00123760 |
Recruitment Status :
Completed
First Posted : July 26, 2005
Last Update Posted : February 25, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Neoplasms Lung Neoplasms Thyroid Neoplasms Colorectal Neoplasms Lymphoma | Procedure: Positron Emission Tomography (PET) scan | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10838 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | February 2004 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

- 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 ]
- 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 ]

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00123760
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 |
Principal Investigator: | Alexander McEwan, MB, MSc, MD, FRCP | AHS Cancer Control Alberta |
Responsible Party: | AHS Cancer Control Alberta |
ClinicalTrials.gov Identifier: | NCT00123760 |
Other Study ID Numbers: |
SP-11-0035/DX-FDG-001/21221 |
First Posted: | July 26, 2005 Key Record Dates |
Last Update Posted: | February 25, 2016 |
Last Verified: | March 2012 |
Positron-Emission Tomography Fluorodeoxyglucose F18 Tomography scanners, X-Ray computed |
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 |