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

NCT00123786 | Terminated Phase 2

• 1 other identifier: MS-12-0009/DX-FDG-005/21933
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Keywords

positron emission tomography; fluorodeoxyglucose F18; tomography scanners, x-ray computed

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Interventions

Positron Emission Tomography PROCEDURE

Positron Emission Tomography

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Alexander McEwan, MD

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2005
• First Posted: July 26, 2005
• Study Start: August 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 25, 2016

Record last verified: 2012-03

Locations

CA (1)