Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

NCT01962909 | Terminated Early Phase 1 DMC

• 1 other identifier: 16678
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic Resection

Outcome Measures

Primary Outcomes (1)

• 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

  up to 72 hours post dose

Secondary Outcomes (3)

• Biodistribution and Binding Characteristics of PTP-01

  up to 7 days post dose

• Clearance of PTP-01

  up to 7 days post dose

• Safety and Tolerability of PTP-01

  up to 30 days post dose

Study Arms (1)

PTP-01

EXPERIMENTAL

single IV bolus dose 24 hours prior to surgery

Drug: PTP-01

Interventions

PTP-01 DRUG

Dose level 1 is 10mCi (50ug of peptide)

PTP-01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• subjects receiving any other investigational agents
• significant history of uncontrolled cardiac disease or central nervous system (CNS) disease
• pregnant or breastfeeding women

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Study Officials

• Reid Adams, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: October 14, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 18, 2016

Record last verified: 2016-03

Locations

US (1)