Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Virginia
Sponsor:
Information provided by (Responsible Party):
Reid Adams, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01962909
First received: June 19, 2013
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Pancreatic Ductal Adenocarcinoma
Drug: PTP-01
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Ability of PTP-01 to detect pancreatic ductal adenocarcinoma [ Time Frame: up to 72 hours post dose ] [ Designated as safety issue: No ]
    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:
  • Biodistribution and Binding Characteristics of PTP-01 [ Time Frame: up to 7 days post dose ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: up to 7 days post dose ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: up to 30 days post dose ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 10
Study Start Date: November 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTP-01
single IV bolus dose 24 hours prior to surgery
Drug: PTP-01
Dose level 1 is 10mCi (50ug of peptide)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962909

Contacts
Contact: Sandra Burks, RN 434-243-0315 sgb2c@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Reid B Adams, MD    434-924-2839    rba3b@virginia.edu   
Sub-Investigator: Patrice K Rehm, MD         
Sponsors and Collaborators
Reid Adams, MD
Investigators
Principal Investigator: Reid Adams, MD University of Virginia
  More Information

No publications provided

Responsible Party: Reid Adams, MD, Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT01962909     History of Changes
Other Study ID Numbers: 16678
Study First Received: June 19, 2013
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by University of Virginia:
Pancreatic Resection

Additional relevant MeSH terms:
Carcinoma, Ductal, Breast
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014