Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

A Phase 0, Open Label Study to Evaluate the Biodistribution and Pharmacokinetics of a Single Intravenous Bolus Dose of PTP-01 in Subjects With Resectable Pancreatic Ductal Adenocarcinoma

The purpose of this clinical trial is to study an experimental drug called PTP-01 that is being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early stage disease. Researchers at the University of Virginia have identified a biomarker for pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other, non-cancerous conditions involving the pancreas. These researchers have also developed PTP-01, an experimental drug that may be used with SPECT imaging to detect pancreatic cancer cells in humans.

Inclusion Criteria:

• subject is undergoing resection of pancreas for pancreatic ductal adenocarcinoma (PDAC)
• subject must have adequate renal function
• ECOG performance status of 0-2
• women of child-bearing age and men must agree to use contraception prior to and during the study

Exclusion Criteria:

• subjects receiving any other investigational agents
• significant history of uncontrolled cardiac disease or central nervous system (CNS) disease
• pregnant or breastfeeding women