An Early Phase 1 interventional study of PTP-01 in Pancreatic Ductal Adenocarcinoma, sponsored by University of Virginia. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-18.
Sponsored by University of Virginia · Early Phase 1, Interventional, and Diagnostic
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.
University of Virginia is the lead sponsor of 672 studies on the registry; 138 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
single IV bolus dose 24 hours prior to surgery
Drug: PTP-01
Dose level 1 is 10mCi (50ug of peptide)
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
Time frame: up to 72 hours post dose
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.
Time frame: 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.
Time frame: 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.
Time frame: up to 30 days post dose
The record gives a start of Nov 2013, a primary completion of Jan 2016 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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