Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Drug: PTP-01


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTP-01<br>single IV bolus dose 24 hours prior to surgery | Drug: PTP-01<br>* Dose level 1 is 10mCi (50ug of peptide)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of PTP-01 to detect pancreatic ductal adenocarcinoma | requires a signal to background ratio of greater than or equal to 2:1 following a single intravenous bolus of PTP-01 | up to 72 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biodistribution and Binding Characteristics of PTP-01 | 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. | up to 7 days post dose | 
| Clearance of PTP-01 | Blood and urine samples will be collected to measure the level of radioactivity at specified intervals following PTP-01 dose. | up to 7 days post dose | 
| Safety and Tolerability of PTP-01 | 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. | up to 30 days post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Resection