Clinical trial · Interventional
Positron Emission Tomography Using Fluorine F 18 EF5 to Find Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Newly Diagnosed Brain Tumors
Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors
- 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 phase I trial is studying the side effects of fluorine F18 EF5 when given during positron emission tomography to find oxygen in tumor cells of patients who are undergoing surgery or biopsy for newly diagnosed brain tumors. Diagnostic procedures using fluorine F 18 EF5 and positron emission tomography to detect tumor hypoxia may help in planning cancer treatment
Conditions
Conditions (27)
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 Brain Stem Glioma | Adult Brain Stem Glioma | ONTOLOGY_EXACT | 0.98 |
| Adult Central Nervous System Germ Cell Tumor | Adult Central Nervous System Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Adult Choroid Plexus Tumor | Adult Choroid Plexus Neoplasm | ALIAS | 0.90 |
| Adult Craniopharyngioma | Adult Craniopharyngioma |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| EF5 | Drug | — | UNRESOLVED |
| fluorine F 18 EF5 | Radiation | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group 1 (fluorine F 18 EF5, PET)
- description
- Patients receive fluorine F 18 EF5 (\^18F-EF5) IV followed by whole brain and whole body PET scanning OR whole body PET scanning only. Patients then receive nonradioactive EF5 IV over 1-2 ½ hours.
- interventionNames
- Procedure: conventional surgery
- Procedure: positron emission tomography
- Radiation: fluorine F 18 EF5
- Other: pharmacological study
- type
- EXPERIMENTAL
- label
- Group 2 (EF5, PET)
- description
- Patients receive nonradioactive EF5 IV over 1-2½ hours followed by \^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.
- interventionNames
- Drug: EF5
- Procedure: conventional surgery
- Procedure: positron emission tomography
- Other: pharmacological study
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 de novo mass that is likely to be a brain tumor * Amenable to debulking surgery or surgical resection or biopsy as standard initial therapy for the tumor * Performance status - Karnofsky 70-100% * At least 3 months * WBC count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin \< 1.2 mg/dL * Creatinine \< 1.3 mg/dL * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No other significant cardiac condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 month after study participation * Weight ≤ 130 kg * No peripheral neuropathy ≥ grade 3 * No history of allergic reaction attributed to metronidazole * No other uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance * No other medical condition that would preclude study participation
References
Publications (0)
Data not yet available