Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
Pancreatic Resection
Brief summary
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.
Interventions
DRUGPTP-01
Dose level 1 is 10mCi (50ug of peptide)
Sponsors
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability of PTP-01 to detect pancreatic ductal adenocarcinoma | up to 72 hours post dose | requires a signal to background ratio of greater than or equal to 2:1 following a single intravenous bolus of PTP-01 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution and Binding Characteristics of PTP-01 | up to 7 days post dose | Assessments will be made from imaging (whole body planar and SPECT/CT) and blood draws following PTP-01 dose. Tissue samples will also be retained for pathology. |
| Clearance of PTP-01 | up to 7 days post dose | Blood and urine samples will be collected to measure the level of radioactivity at specified intervals following PTP-01 dose. |
| Safety and Tolerability of PTP-01 | up to 30 days post dose | Clincial labs, ECGs, vital signs and physical exams will be performed up to 7 days post dose. Adverse events will be collected up to 30 days post dose. |
Countries
United States
Outcome results
None listed