Back to resultsPhase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer
Primary Purpose
Pancreatic Ductal Adenocarcinoma
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
PTP-01
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Ductal Adenocarcinoma focused on measuring Pancreatic Resection
Eligibility 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
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PTP-01
Arm Description
single IV bolus dose 24 hours prior to surgery
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Clearance of PTP-01
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01962909
Brief Title
Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
From preliminary imaging data, the study was stopped due to futility.
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Virginia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma
Keywords
Pancreatic Resection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTP-01
Arm Type
Experimental
Arm Description
single IV bolus dose 24 hours prior to surgery
Intervention Type
Drug
Intervention Name(s)
PTP-01
Intervention Description
Dose level 1 is 10mCi (50ug of peptide)
Primary Outcome Measure Information:
Title
Ability of PTP-01 to detect pancreatic ductal adenocarcinoma
Description
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 Outcome Measure Information:
Title
Biodistribution and Binding Characteristics of PTP-01
Description
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
Title
Clearance of PTP-01
Description
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
Title
Safety and Tolerability of PTP-01
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reid Adams, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer
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