EF5 Compared With Other Methods of Detecting Oxygen Levels in Tumor Cells of Patients With Head and Neck Cancer
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|