Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-01-31

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.

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Detailed Description

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Conditions

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Pancreatic Ductal Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PTP-01

single IV bolus dose 24 hours prior to surgery

Group Type EXPERIMENTAL

PTP-01

Intervention Type DRUG

Dose level 1 is 10mCi (50ug of peptide)

Interventions

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PTP-01

Dose level 1 is 10mCi (50ug of peptide)

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No