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Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

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University of Virginia

Status and phase

Terminated
Early Phase 1

Conditions

Pancreatic Ductal Adenocarcinoma

Treatments

Drug: PTP-01

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

PTP-01
Experimental group
Description:
single IV bolus dose 24 hours prior to surgery
Treatment:
Drug: PTP-01

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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