Phase 0 Biodistribution Of Novel Imaging For Resectable Pancreatic Cancer

Study Overview

Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

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.

N/A

Pancreatic Ductal Adenocarcinoma

DRUG: PTP-01

16678

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-06-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-03-16
First Submitted that Met QC Criteria 2013-10-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-03-18
First Posted (ESTIMATED) 2013-10-14	Results First Posted N/A	Last Verified 2016-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: PTP-01 single IV bolus dose 24 hours prior to surgery	DRUG: PTP-01 Dose level 1 is 10mCi (50ug of peptide)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: PTP-01

single IV bolus dose 24 hours prior to surgery

DRUG: PTP-01

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

subjects receiving any other investigational agents
significant history of uncontrolled cardiac disease or central nervous system (CNS) disease
pregnant or breastfeeding women

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Reid Adams, MD, University of Virginia

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record