Study of Intratumoral Hypoxia Using Pre-operative Administration of Pimonidazole
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
pancreas, pancreatic cancer, pancreatic tumor, pimonidazole, hypoxia, whipple's resection
Study Type
Observational
Study Phase
N/A
Study Design
N/A
Intervention
Name: Pimonidazole hydrochloride
Type: Drug
Overall Status
Recruiting
Summary
This study involves the administration of a hypoxia marker, pimonidazole hydrochloride, taken orally approximately 24 hours before surgical resection of a pancreatic tumor in order to identify areas of lower oxygen content on tumor samples.
Detailed Description
Intratumoral 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 tumor 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 tumors 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 tumors.

We propose accrual of patients over a 5-year period to evaluate hypoxia within 100 clinical tumor 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 intratumoral hypoxia and cell proliferation, differentiation, and the expression of putative cancer stem cell markers.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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)
Location
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Status: Recruiting
Contact: Neesha Dhani, MD - 416-946-4501 - neesha.dhani@uhn.on.ca
Start Date
October 2010
Sponsors
University Health Network, Toronto
Source
University Health Network, Toronto
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page