Trial Information

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

Background: Positron Emission Tomography (PET) is a specialized nuclear medicine procedure
that uses positron emitting radiolabeled tracer molecules to measure biological activity.
The most common of these tracers, 18F-2-fluoro-2-deoxyglucose (FGD), an analog of glucose,
is used to determine abnormal glucose metabolism in tumours and other sites. FDG has general
applications where abnormal glucose metabolism may be present such as differentiating
tumour from scar tissue, evaluating the presence of tumour in light of rising tumour markers
and normal morphological imaging, and assessing response to therapy.

The Cross Cancer Institute has been funded to establish a PET centre and research program to
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.
A cyclotron has been installed at the Cross Cancer Institute which produces 18F-fluoride
that is used in the automated synthesis of FDG. The three PET scanners in the Department of
Oncologic Imaging will be used for this protocol.

Objectives:

Primary - establish the general utility and value of FDG-PET imaging in patients with known
or suspected soft tissue sarcoma.

Secondary - demonstrate the safety of FDG-PET imaging by documentation of adverse events;
determine whether the number of subjects available for study at the Cross Cancer Institute
is sufficient to achieve statistically significant results; determine the feasibility of
extending this study to a larger multicenter design.

Study Design: The proposed trial will be a Phase II, diagnostic imaging, open label, single
site clinical trial. The patient population will consist of patients with known or
suspected soft tissue sarcoma. This will also be a pilot study to test the feasibility of
extending this trial to a larger multicenter design in view of increasing sample size and
strengthening conclusions about safety and effectiveness of FDG-PET imaging in this
population.

With each scan, the patient will receive a single IV injection of FDG. Initial imaging will
be conducted 60 minutes after an average injection of 200-300 MBq of FDG (dose is dependent
on which scanner is used and patients' weight). The images will then be examined by an
experienced nuclear medicine physician and the location and intensity of abnormal FDG uptake
will be reported. The referring physician will then correlate the findings with the results
of clinical examinations and conventional imaging.

Statistical Analysis: The investigators will calculate the positive predictive value (PPV)
of the FDG scans. They also intend to evaluate the percentage of patients in which the FDG
scan outcome affected patient management.

Stopping Rules: The subject is free to withdraw at any time. The investigator also has the
right to withdraw a subject from the study in the event of intercurrent illness or other
reasons concerning the health or well being of the subject, or in case of lack of
cooperation. Should a subject decide to withdraw or the investigator decide to withdraw the
subject after administration of FDG, all efforts will be made to complete and report
follow-up observations as thoroughly as possible providing consent is still valid. A
complete final evaluation at the time of the subject's withdrawal is to be made with an
explanation of why the subject is withdrawing or being withdrawn from the study. If the
reason for withdrawing a subject from the study is a specific event or an abnormal
laboratory test result, the event or test result must be recorded as an adverse event and
entered into the Case Report Form.

Data Safety Monitoring Committee: Preliminary data will be analyzed for safety and
effectiveness on a yearly basis until the study ends.