Clinical trial · Interventional
Fluorine F18-EF5 and Fludeoxyglucose F18 Positron Emission Tomography in Assessing Hypoxia and Glycolysis in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Assessing Hypoxia by 18F-EF5 PET Scanning and Glycolysis by 18FFDG PET Scanning in Subjects With Non-Small Cell Lung Cancer
NCT01017133CI-TRIAL-00008156completedPhase 1ClinicalTrials.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, such as positron emission tomography, using the drug fluorine F18-EF5 to find oxygen and fludeoxyglucose F18 to find sugar in tumor cells may help in planning treatment for patients with non-small cell lung 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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| Fluorine F 18 EF5 | Radiation | — | UNRESOLVED |
| Positron emission tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Arm I
- description
- With 6 weeks prior to surgery, patients undergo fluorine F18 (18F)-EF5 PET at 10 minutes and 90 minutes after injection of 18F-EF5. Patients also undergo fludeoxyglucose F18 (18F-FDG) PET at 1 hour and 3 hours after injection of 18F-FDG.
- interventionNames
- Radiation: fludeoxyglucose F 18
- Radiation: Fluorine F 18 EF5
- Procedure: Positron emission tomography
Primary outcomes (6)
- measure
- P-Akt in tumor cells as assessed by immunohistochemistry
- measure
- Tumor hypoxia as assessed by 18F-EF5 PET imaging
- measure
- Tumor Glycolysis as assessed by 18F-FDG PET imaging
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must have a histologically confirmed NSCLC or clinical and imaging evidence of a de novo mass that is likely to be a NSCLC, stage I, II, or IIIA, for which surgery would be indicated for routine medical indications * ECOG performance status between 0 and 2 * Subjects must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits * WBC \> 2,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Total bilirubin * Serum AST and ALT * Serum creatinine * Negative serum pregnancy test if a female of childbearing age Exclusion Criteria: * History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5 * Uncontrolled intercurrent illness that would limit compliance with study requirements * Pregnant women and women who are breastfeeding are excluded * Subjects who have been treated with neoadjuvant radiation or chemotherapy prior to their biopsy or excision are excluded because the impact of these therapies upon the degree of hypoxia of the tumor is unknown
References
Publications (0)
Data not yet available
No reference posted for this study.