Head and Neck Cancer Clinical Trial
Official title:
Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in Head and Neck Cancer
Verified date | February 2013 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | |
Est. primary completion date | October 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the head and neck - Clinically detectable disease by physical examination or radiographic studies - Scheduled to undergo surgical resection of tumor or radiotherapeutic treatment PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL Renal - Creatinine no greater than 1.8 mg/dL Other - No allergy to IV contrast dye - No prior grade III or IV peripheral neuropathy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 week after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - Concurrent radiotherapy allowed Surgery - See Disease Characteristics |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
David M. Brizel, MD | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual | One Year | No | |
Primary | Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual | One year | No | |
Primary | Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual | One Year | No | |
Primary | Spatial coordination as measured by EF5 binding at completion of accrual | One Year | No | |
Primary | Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual | One year | No |
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