Phase 0 Biodistribution of Novel Imaging for Resectable P... | NCT01962909

Studies
Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

NCT01962909

Sponsor

University of Virginia

Status

Terminated

Last Update Posted

Mar 18, 2016Estimated

Enrollment

3Actual

Phase

Early Phase 1

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

PTP-01

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

From preliminary imaging data, the study was stopped due to futility.

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jun 19, 2013

First Submission Date that Met QC Criteria

Oct 10, 2013

First Posted Date

Oct 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2016

Last Update Posted Date

Mar 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PTP-01	Experimental	single IV bolus dose 24 hours prior to surgery	Drug: PTP-01

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PTP-01	Drug	Dose level 1 is 10mCi (50ug of peptide)	PTP-01

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	up to 7 days post dose
Clearance of PTP-01

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Reid Adams, MD	University of Virginia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22908	United States