A Study Using 18F-FAZA and PET Scans to Study Hypoxia in Pancreatic Cancer

This is a single centre, single arm hypoxia study of pancreatic cancer with PET FAZA imaging.

PET-CT imaging of tumor hypoxia with FAZA will be done prior to the start of standard treatment for pancreatic cancer with chemotherapy. The FAZA PET-CT imaging session will last approximately 2.5 hours and include an initial dynamic scan to completely characterize the initial rapid phase of FAZA uptake, followed by a later static scan.

Inclusion criteria

• Minimum age of 18 years old
• Histologic diagnosis of pancreatic adenocarcinoma
• TNM (7th edition) cT1-4, N0-1, M0-1
• No cytotoxic anti-cancer therapy for advanced / metastatic pancreatic cancer prior to study entry
• Ability to provide written informed consent to participate in the study
• ECOG performance status 0, 1 or 2.
• Patient should have the following blood counts at baseline: ANC equal or greater to 1.5 x 109/L; Platelets equal or greater to 100 x 109/L; Hgb equal or greater to 9g/Dl
• Patient should have the following blood chemistry levels at baseline: AST (SGOT), ALT (SGPT) equal or less than 5 x upper limit of normal range (ULN) is allowed
• Patient has an identifiable tumor (pancreatic tumor and/or metastasis) by imaging (CT scan and/or MR)
• Patient must agree to use contraception considered adequate and appropriate by the investigator and if the patient is female of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (B-hCG)

Exclusion criteria

• Inability to lie supine for more than 30 minutes
• Any other type of primary cancer
• Life expectancy of less than 12 weeks
• Patient has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids and stable in two scans at least 4 weeks apart)
• Patient has serious medical risk factors involving any of the major organ systems