Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01962909
Recruitment Status : Terminated (From preliminary imaging data, the study was stopped due to futility.)
First Posted : October 14, 2013
Last Update Posted : March 18, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Drug: PTP-01 Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : November 2013
Primary Completion Date : January 2016
Study Completion Date : January 2016

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 :
  1. Ability of PTP-01 to detect pancreatic ductal adenocarcinoma [ Time Frame: 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 :
  1. Biodistribution and Binding Characteristics of PTP-01 [ Time Frame: 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.

  2. Clearance of PTP-01 [ Time Frame: 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.

  3. Safety and Tolerability of PTP-01 [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01962909

United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Principal Investigator: Reid Adams, MD University of Virginia

Responsible Party: University of Virginia Identifier: NCT01962909     History of Changes
Other Study ID Numbers: 16678
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016

Keywords provided by University of Virginia:
Pancreatic Resection

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type