Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Soft Tissue Sarcoma
This study is ongoing, but not recruiting participants.
Sponsored by: Alberta Cancer Board
Information provided by: Alberta Cancer Board
ClinicalTrials.gov Identifier: NCT00123786
  Purpose

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 Intervention Phase
Sarcoma
Procedure: Positron Emission Tomography
Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
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 II Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Soft Tissue Sarcoma

Further study details as provided by Alberta Cancer Board:

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

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

Estimated Enrollment: 50
Study Start Date: August 2005
Estimated Study Completion Date: November 2007
  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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123786

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Cancer Board
Investigators
Principal Investigator: Alexander McEwan, MD Alberta Cancer Board
  More Information

Study ID Numbers: MS-12-0009
Study First Received: July 22, 2005
Last Updated: September 22, 2008
ClinicalTrials.gov Identifier: NCT00123786  
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:
Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor
Sarcoma
Deoxyglucose
Soft tissue sarcomas

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009