Clinical trial · Observational
Study of Intratumoral Hypoxia Using Pre-operative Administration of Pimonidazole
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.
NCT01248637CI-TRIAL-00117631completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pimonidazole hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pimonidazole hydrochloride
- description
- Oral pimonidazole is administered at a dose of 0.5gm/m2 once approximately 24 hrs prior to surgery
- interventionNames
- Drug: Pimonidazole hydrochloride
Primary outcomes (2)
- measure
- characterization of intratumoral hypoxia in pancreatic cancer
- timeFrame
- 5 Years
- description
- estimation of tumoral hypoxic fraction by immunodetection of pimonidazole adducts.
- measure
- correlation of intratumoral hypoxia with patient survival rate
- timeFrame
- 5 Years
- description
- evaluation of correlation of tumoral hypoxia with disease-free survival using Cox proportional hazards analysis
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDDhani 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