Study of Intratumoral Hypoxia Using Pre-operative Administration of Pimonidazole

NCT01248637 | Completed

• 2 other identifiers: PIMO-PANCUHN REB 10-0350-C
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

pancreas; pancreatic cancer; pancreatic tumor; pimonidazole; hypoxia; whipple's resection

Outcome Measures

Primary Outcomes (2)

• characterization of intratumoral hypoxia in pancreatic cancer

  estimation of tumoral hypoxic fraction by immunodetection of pimonidazole adducts.

  5 Years

• correlation of intratumoral hypoxia with patient survival rate

  evaluation of correlation of tumoral hypoxia with disease-free survival using Cox proportional hazards analysis

  5 Years

Secondary Outcomes (2)

• correlation of hypoxia with molecular markers

  5 Years

• to assess utility of circulating osteopontin and miR-210 for identifying hypoxia

  5 Years

Study Arms (1)

Pimonidazole hydrochloride

Oral pimonidazole is administered at a dose of 0.5gm/m2 once approximately 24 hrs prior to surgery

Drug: Pimonidazole hydrochloride

Interventions

Pimonidazole hydrochloride DRUG

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 orally as a one time dose of 0.5gm/m2 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.

Also known as: Hypoxyprobe-1

Pimonidazole hydrochloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participating in ICGC Pancreatic Cancer Genome Project.

You may qualify if:

• 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)

You may not qualify if:

• not participating in ICGC
• contraindications to pimonidazole (allergy)
• surgery scheduled for same or next day (not enough time to arrange for drug administration)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Dhani NC, Serra S, Pintilie M, Schwock J, Xu J, Gallinger S, Hill RP, Hedley DW. Analysis of the intra- and intertumoral heterogeneity of hypoxia in pancreatic cancer patients receiving the nitroimidazole tracer pimonidazole. Br J Cancer. 2015 Sep 15;113(6):864-71. doi: 10.1038/bjc.2015.284. Epub 2015 Sep 1.

  PMID: 26325106 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Pancreatic Tumor biopsy and blood samples.

MeSH Terms

Conditions

Pancreatic Neoplasms; Hypoxia

Interventions

pimonidazole

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Neesha Dhani, MD

  Univeristy Health Network - Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 25, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 30, 2018

Record last verified: 2018-07

Locations

CA (1)