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Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00123786
Recruitment Status : Terminated (Lack of Enrollment)
First Posted : July 26, 2005
Last Update Posted : February 25, 2016
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
18F-fluorodeoxyglucose (18F-FDG) has been approved by many regulatory agencies world-wide and is in widespread use in the United States, Japan and Europe. In the United States, 18F-FDG scanning in oncology is approved for federal healthcare reimbursement for non-Hodgkin's lymphoma, Hodgkin's disease, colorectal cancer, lung cancer, oesophageal cancer, melanoma, head and neck cancer and breast cancer. 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 imaging techniques; and assessing response to therapy where other techniques are deemed to be unhelpful. Current literature suggests that functional imaging with 18F-FDG Positron Emission Tomography (PET) may play an important role in the imaging evaluation of patients with soft tissue sarcoma, including guiding biopsy; detecting local recurrence at sites of tumour resection; detecting metastatic disease; predicting and monitoring response to therapy; and assessing for prognosis. In appropriate situations, it is possibly the most effective diagnostic strategy. However, due to the low incidence of these tumours, prospective studies with large multicenter patient groups will be essential to define the exact diagnostic role of 18F-FDG PET in this clinical setting.

Condition or disease Intervention/treatment Phase
Sarcoma Procedure: Positron Emission Tomography Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase II Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Soft Tissue Sarcoma
Study Start Date : August 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Positron Emission Tomography
    Positron Emission Tomography

Primary Outcome Measures :
  1. establish the general utility, value and clinical relevance of FDG-PET imaging in patients with known or suspected soft tissue sarcoma
  2. demonstrate the safety of FDG-PET by documentation of adverse events

Secondary Outcome Measures :
  1. determine whether the number of subjects available for study at the Cross Cancer Institute (CCI) is sufficient to achieve statistically significant results
  2. determine the feasibility of extending this study to a larger multicenter design

Information from the National Library of Medicine

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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 soft tissue sarcoma
  • 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
  • Age less than 15 years
  • A history of malignancy other than soft-tissue sarcoma (excluding basal cell carcinoma and cervical intraepithelial neoplasia)

Recruitment: Study subjects will be referred to the Cross Cancer Oncologic Imaging Department by their physicians. The patient's study eligibility will be confirmed during the booking telephone call and eligible, interested patients will be scheduled for a PET scan.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00123786

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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
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Principal Investigator: Alexander McEwan, MD AHS Cancer Control Alberta
Additional Information:
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Responsible Party: AHS Cancer Control Alberta Identifier: NCT00123786    
Other Study ID Numbers: MS-12-0009/DX-FDG-005/21933
First Posted: July 26, 2005    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: March 2012
Keywords provided by AHS Cancer Control Alberta:
positron emission tomography
fluorodeoxyglucose F18
tomography scanners, x-ray computed
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type