Clinical trial · Interventional
EF5 Compared With Other Methods of Detecting Oxygen Levels in Tumor Cells of Patients With Head and Neck Cancer
Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in Head and Neck Cancer
NCT00049140CI-TRIAL-00015214completedPhase 2ClinicalTrials.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)
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.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bioluminescence | Other | — | UNRESOLVED |
| biopsy | Procedure | — | UNRESOLVED |
| EF5 | Drug | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EF5
- description
- This is a non randomised single arm pilot study.
- interventionNames
- Drug: EF5
- Other: bioluminescence
- Other: flow cytometry
- Other: immunohistochemistry staining method
- Procedure: biopsy
Primary outcomes (5)
- measure
- Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual
- timeFrame
- One Year
- measure
- Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual
- timeFrame
- One year
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.