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Study of Intratumoral Hypoxia Using Pre-operative Administration of Pimonidazole

This study is currently recruiting participants.
Verified June 2012 by University Health Network, Toronto
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01248637
First received: November 24, 2010
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248637

Contacts
Contact: Neesha Dhani, MD 416-946-4501 ext 4921 neesha.dhani@uhn.on.ca
Contact: David Hedley, MD 416-946-4501 ext 3428 david.hedley@uhn.on.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Neesha Dhani, MD     416-946-4501 ext 4921     neesha.dhani@uhn.on.ca    
Principal Investigator: David Hedley, MD            
Principal Investigator: Richard Hill, MD            
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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
ClinicalTrials.gov 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:
pancreas
pancreatic cancer
pancreatic tumor
 pimonidazole
hypoxia
whipple's resection

Additional relevant MeSH terms:
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancreatic Neoplasms
Anoxia
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Signs and Symptoms, Respiratory
Signs and Symptoms
Pimonidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013