Clinical trial · Interventional
Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma
Assessment of Hypoxia in Malignant Gliomas Using EF5
NCT00430079CI-TRIAL-00008919terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
This clinical trial is using EF5 to measure the oxygen level in tumor cells of patients undergoing surgery or surgery biopsy for newly diagnosed supratentorial malignant glioma. Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Anaplastic Astrocytoma | Adult Anaplastic Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Anaplastic Ependymoma | Adult Anaplastic Ependymoma | ONTOLOGY_EXACT | 0.98 |
| Adult Anaplastic Oligodendroglioma | Adult Anaplastic Oligodendroglioma | ONTOLOGY_EXACT | 0.98 |
| Adult Diffuse Astrocytoma | Adult Diffuse Astrocytoma | ONTOLOGY_EXACT | 0.98 |
| Adult Ependymoma | Adult Ependymoma | ONTOLOGY_EXACT | 0.98 |
| Adult Giant Cell Glioblastoma | Adult Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Gliosarcoma | Adult Gliosarcoma | ONTOLOGY_EXACT | 0.98 |
| Adult Mixed Glioma | Adult Mixed Glioma |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| etanidazole | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (etanidazole)
- description
- Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.
- interventionNames
- Drug: etanidazole
- Procedure: conventional surgery
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Time to local recurrence
- timeFrame
- Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed and/or clinical and imaging evidence of a new brain mass that is likely to be a supratentorial malignant glioma * Clinical condition and physiologic status indicative of debulking surgery or biopsy as standard initial therapy * Performance status - Karnofsky performance status 60-100% * WBC greater than 2,000/mm\^3 * Platelet count greater than 90,000/mm\^3 * Creatinine less than 2.0 mg/dL * No significant cardiac condition that would preclude study therapy * No symptomatic congestive heart failure * No unstable angina pectoris * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 month after study completion * Weight no greater than 130 kilograms * No grade 3 or 4 peripheral neuropathy * No other invasive malignancy within the past 3 years that is likely to cause a solitary supratentorial metastasis * No uncontrolled concurrent illness, medical condition, psychiatric illness, or social situation that would preclude study participation * At least 6 months since prior chemotherapy * Concurrent corticosteroid therapy allowed * At least 6 months since prior radiotherapy to lesion or site of lesion * At least 6 months since prior surgery to lesion or site of lesion except incisional or core biopsy * Concurrent anticonvulsant therapy allowed * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.