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A Clinical Trial of Intratumoral Hypoxia and Its Biologic Correlates in Patients Undergoing Surgical Resection of Localized Pancreatic Cancer, Using Pre-operative Administration of the Hypoxia Marker Pimonidazole.


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

A Clinical Trial of Intratumoral Hypoxia and Its Biologic Correlates in Patients Undergoing Surgical Resection of Localized Pancreatic Cancer, Using Pre-operative Administration of the Hypoxia Marker Pimonidazole.


This study involves the intravenous (given by vein) administration of a hypoxia marker,
pimonidazole hydrochloride, approximately 24 hours before surgery for pancreatic tumor in
order to identify areas of lower oxygen content on samples of your tumour.

Pimonidazole is a drug that, when given intravenously, will attach to areas in the tumour
that is low in oxygen. When this happens, the areas that are low in oxygen can be more
easily found and studied.

We will collect tumour samples from about 100 patients to study hypoxia and other biologic
processes in clinical pancreatic cancer as well as animal (mouse) models of these cancers.
Since patient samples are being collected as part of the Pancreatic Cancer Genome project
(designed to collect 500 patient samples) we developed this companion study to characterize
patient tumours with respect to hypoxia.


Inclusion Criteria:



- age > 18

- provisional diagnosis of pancreatic cancer

- scheduled resection at UHN

- consented to ICGC Pancreatic Cancer Genome Project

- surgery planned for >2 days away (drug administration has to be 16-20hrs before
surgery)

Exclusion Criteria:

- not participating in ICGC

- contraindications to pimonidazole (allergy)

- surgery scheduled for same or next day (not enough time to arrange for drug
administration)

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

characterization of intratumoral hypoxia in pancreatic cancer

Outcome Description:

estimation of tumoral hypoxic fraction by immunodetection of pimonidazole adducts.

Outcome Time Frame:

5 Years

Safety Issue:

No

Principal Investigator

David Hedley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Univeristy Health Network - Princess Margaret Hospital

Authority:

Canada: Ethics Review Committee

Study ID:

PIMO-PANC

NCT ID:

NCT01248637

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • pancreas
  • pancreatic cancer
  • pancreatic tumor
  • pimonidazole
  • hypoxia
  • whipple's resection
  • Pancreatic Neoplasms
  • Anoxia

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