Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

Early Phase 1

Terminated

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Drug: PTP-01

• Registration Number: NCT01962909
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-14
• Study Start: 2013-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PTP-01	PTP-01	single IV bolus dose 24 hours prior to surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States