Clinical trial · Interventional
Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): From preliminary imaging data, the study was stopped due to futility.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTP-01 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PTP-01
- description
- single IV bolus dose 24 hours prior to surgery
- interventionNames
- Drug: PTP-01
Primary outcomes (1)
- measure
- Ability of PTP-01 to detect pancreatic ductal adenocarcinoma
- timeFrame
- up to 72 hours post dose
- description
- requires a signal to background ratio of greater than or equal to 2:1 following a single intravenous bolus of PTP-01
Secondary outcomes (3)
- measure
- Biodistribution and Binding Characteristics of PTP-01
- timeFrame
- up to 7 days post dose
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available