Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

Early Phase 1TerminatedNCT01962909

University of Virginia3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: up to 72 hours post dose

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: up to 30 days post dose