Study of Intratumoural Hypoxia Using Pre-operative Administration of Pimonidazole

Official Title

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

Summary:

This study involves the administration of a hypoxia marker, pimonidazole hydrochloride, taken orally approximately 24 hours before surgical resection of a pancreatic tumour in order to identify areas of lower oxygen content on tumour samples.

Trial Description

Primary Outcome:

  • characterization of intratumoural hypoxia in pancreatic cancer
  • correlation of intratumoural hypoxia with patient survival rate
Secondary Outcome:
  • correlation of hypoxia with molecular markers
  • to assess utility of circulating osteopontin and miR-210 for identifying hypoxia
Intratumoural hypoxia (low oxygen concentration or pO2) occurs when oxygen consumption exceeds its delivery by the vascular system. Hypoxia is associated with adverse patient outcome in many human cancers and this association is hypothesized to be due to a combination of treatment resistance and aggressive tumour biology. The study of hypoxia is also important as new cancer drugs are being developed that are specifically active on cancer cells in area of tumours with lower oxygen levels. his study involves administering the hypoxia probe pimonidazole hydrochloride to patients prior to resection of pancreatic adenocarcinoma to evaluate the extent, molecular context and clinical relevance of hypoxia in clinical pancreatic cancer samples and the subsequently derived primary xenograft tumours. We propose accrual of patients over a 5-year period to evaluate hypoxia within 100 clinical tumour specimens and corresponding primary xenograft tumours where available. The complementary techniques of wide-field multicolor fluorescence image analysis microscopy and high level flow cytometry will be used to identify potential relationships between intratumoural hypoxia and cell proliferation, differentiation, and the expression of putative cancer stem cell markers.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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