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.
|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|
- 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
- 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.
|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)|
single IV bolus dose 24 hours prior to surgery
Dose level 1 is 10mCi (50ug of peptide)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01962909
|Contact: Sandra Burks, RNemail@example.com|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Reid B Adams, MD 434-924-2839 firstname.lastname@example.org|
|Sub-Investigator: Patrice K Rehm, MD|
|Principal Investigator:||Reid Adams, MD||University of Virginia|