Trial Information

A Phase II Study of F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Cancers of Low Incidence

Background

Positron Emission Tomography (PET) is a specialised nuclear medicine procedure that uses
positron emitting radiolabeled tracer molecules to measure biological activity. The most
common of these radiolabeled tracers is 18F-fluorodeoxyglucose (18F-FDG), which is used to
determine abnormal glucose metabolism in tumours and other sites. 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 morphological imaging techniques;
and assessing response to therapy where other techniques are deemed to be unhelpful.

The Cross Cancer Institute has recently been funded to establish a PET centre that will
establish a research programme 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.

Objectives

Primary Objective - The objective of the clinical trial is to establish the general utility
and value of 18F-FDG PET imaging in patients with known or suspected myeloma, sarcoma,
testicular cancer (seminomatous and non-seminomatous germ cell tumors), endometrial cancer,
ovarian cancer, cervical cancer, transitional cell carcinoma of the bladder, renal cell
carcinoma, pancreatic, adenocarcinoma, mesothelioma and gastric cancer.

Secondary Objectives - The secondary objective of the clinical trial is to demonstrate the
safety by documentation of adverse events.

Study Design

The proposed clinical trial will be a Phase II, diagnostic imaging, open label, single site,
clinical trial in patients with defined oncologic disease. The patient population will
consist of patients with suspected or known infrequently occurring cancers, which are not
covered by Protocol DX-FDG-001. This population includes patients with known or suspected
myeloma, sarcoma, testicular cancer (seminomatous and non-seminomatous germ cell tumors),
endometrial cancer, ovarian cancer, cervical cancer, transitional cell carcinoma of the
bladder, renal cell carcinoma, pancreatic adenocarcinoma, mesothelioma and gastric cancer.

Each patient will receive a single IV injection of 18F-FDG. Imaging will be conducted 60
minutes after an average injection of 200 - 300 MBq of 18F-FDG in hydrated, fasted patients.
Images will be collected for 40 to 60 minutes in 5 - 7 body positions (total counts 5 to 15
million) using either the C-PET, Allegro or Gemini PET scanners located in Nuclear Medicine.
Standard transaxial images will be reconstructed from the collected data and can be
re-oriented into coronal or sagittal slices as required. The images will then be examined by
an experienced nuclear medicine physician with regard to normal physiological uptake of
18F-FDG. The location and intensity of abnormal 18F-FDG uptake will be noted and correlated
with clinical findings, and conventional imaging techniques, as available.

Statistical Analyses

Sample Size

The study will enrol approximately 220 subjects, with an approximate maximum of 20 subjects
per specific tumour type (myeloma, sarcoma, testicular cancer [seminomatous and
non-seminomatous germ cell tumors], endometrial cancer, ovarian cancer, cervical cancer,
transitional cell carcinoma of the bladder, renal cell carcinoma, pancreatic adenocarcinoma,
mesothelioma and gastric cancer).

Statistical Analyses

For each group, the investigators will calculate the positive predictive value (true
positive outcomes/true positive outcomes + false positive outcomes) of the 18F-FDG scan.
They also intend to evaluate the percentage of patients in which the 18F-FDG outcome
affected patient management.

Criteria for Evaluability of Study Subject Data

All subjects receiving 18F -FDG will be evaluated for safety and efficacy.

Study Population

Number of Subjects to be Studied

Approximately 220 patients overall; approximately 20 in each cancer type.

Inclusion Criteria for Selection of Study Subjects

Patients will be included in the study if they meet all of the following criteria.

1. 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 pregnancy test.

2. Known or suspected primary or metastatic tumours of myeloma, sarcoma, testicular cancer
(seminomatous and non-seminomatous germ cell tumors), endometrial cancer, ovarian
cancer, cervical cancer, transitional cell carcinoma of the bladder, renal cell
carcinoma, pancreatic adenocarcinoma, mesothelioma and gastric cancer.

3. Age greater than or equal to 15 years.

4. Able and willing to follow instructions and comply with the protocol.

5. Provide written informed consent prior to participation in this study.

7. Karnofsky Performance Scale score 60 - 100.

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:

1. Having had surgery or radiotherapy within 10 days of the planned imaging study.

2. Nursing or pregnant females.

3. Age less than 15 years.