Study of Intratumoral Hypoxia Using Pre-operative Administration of Pimonidazole

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University Health Network, Toronto
Information provided by:
University Health Network, Toronto Identifier:
First received: November 24, 2010
Last updated: June 18, 2012
Last verified: June 2012

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.

Condition Intervention
Pancreatic Cancer
Drug: Pimonidazole hydrochloride

Study Type: Observational
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • characterization of intratumoral hypoxia in pancreatic cancer [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    estimation of tumoral hypoxic fraction by immunodetection of pimonidazole adducts.

  • correlation of intratumoral hypoxia with patient survival rate [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    evaluation of correlation of tumoral hypoxia with disease-free survival using Cox proportional hazards analysis

Secondary Outcome Measures:
  • correlation of hypoxia with molecular markers [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    colocalization of molecular markers using immunofluorescence microscopy: Stem-cell like populations markers of EMT Endogenous markers of hypoxia (HIF1a, CAIX)

  • to assess utility of circulating osteopontin and miR-210 for identifying hypoxia [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    correlation of tumoral hypoxic fraction with plasma levels of osteopontin and miR-210

Biospecimen Retention:   Samples With DNA

Pancreatic Tumor biopsy and blood samples.

Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pimonidazole Drug: Pimonidazole hydrochloride
Pimonidazole is a 2-nitroimidazole that is selectively reduced and covalently binds to intracellular macromolecules in areas of hypoxia (by definition, p02 <= 10mm Hg) within normal and tumour tissue. Pimonidazole adducts can then be detected by immunolabelling techniques (microscopy, ELISA, flow cytometry etc). In this study, pimonidazole will be administered intravenously as a one time dose of 0.5gm/m2 (with a maximum dose of 1gm) 24hrs prior to surgery. Since the drug has a half-life of approximately 5 hrs, this time-frame ensures low circulating levels at the time of surgery and therefore reduces the confounding effects of surgical hypoxia on tumour analysis.
Other Name: Hypoxyprobe-1

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participating in ICGC Pancreatic Cancer Genome Project.


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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01248637

Contact: Neesha Dhani, MD 416-946-4501 ext 4921
Contact: David Hedley, MD 416-946-4501 ext 3428

Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Neesha Dhani, MD    416-946-4501 ext 4921   
Principal Investigator: David Hedley, MD         
Principal Investigator: Richard Hill, MD         
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: David Hedley, MD Univeristy Health Network - Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: Dr. David Hedley, University Health Network, Toronto Identifier: NCT01248637     History of Changes
Other Study ID Numbers: PIMO-PANC, UHN REB 10-0350-C
Study First Received: November 24, 2010
Last Updated: June 18, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University Health Network, Toronto:
pancreatic cancer
pancreatic tumor
whipple's resection

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on July 01, 2015