EF5 Compared With Other Methods of Detecting Oxygen Levels in Tumor Cells of Patients With Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00049140|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 25, 2014
RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors.
PURPOSE: Phase II trial to compare diagnostic procedures using EF5 to that of other methods of detecting oxygen levels in tumor cells of patients who have head and neck cancer.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: EF5 Other: bioluminescence Other: flow cytometry Other: immunohistochemistry staining method Procedure: biopsy||Phase 2|
- Determine the distribution, degree, and intrapatient and interpatient heterogeneity of hypoxia, as measured by EF5 binding in tumor tissue, in patients with head and neck cancer.
- Determine the distribution and intrapatient and interpatient heterogeneity of CA9 expression, as measured immunohistochemically, in these patients.
- Determine the distribution, concentration, and intrapatient and interpatient heterogeneity of glucose and lactate, as measured by bioluminescence imaging, in these patients.
- Determine whether there is spatial coordination between concentrations of lactate and glucose and the location of tissue hypoxia in these patients.
- Determine whether there is spatial coordination between the location of CA9 with hypoxia and/or lactate concentrations in these patients.
OUTLINE: Patients receive EF5 IV over 1-2.5 hours on day 1. Within 24-55 hours after EF5 infusion, patients undergo surgery.
Tumor tissue samples are examined for EF5 binding by immunohistochemistry, bioluminescence imaging, and flow cytometry.
Patients are followed at 1 month and then for survival.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in Head and Neck Cancer|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||October 2004|
This is a non randomised single arm pilot study.
|Drug: EF5 Other: bioluminescence Other: flow cytometry Other: immunohistochemistry staining method Procedure: biopsy|
- Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual [ Time Frame: One Year ]
- Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual [ Time Frame: One year ]
- Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual [ Time Frame: One Year ]
- Spatial coordination as measured by EF5 binding at completion of accrual [ Time Frame: One Year ]
- Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual [ Time Frame: One year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049140
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||David M. Brizel, MD||Duke University|