Clinical trial · Interventional
Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
NCT01774760CI-TRIAL-00041007completedPhase 2Results postedClinicalTrials.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)
The results of previous studies suggest further development of \[18F\]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of \[18F\]EF5 intratumor distribution using repeated pretreatment PET/CT scans.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-EF5 | Drug | — | UNRESOLVED |
| Pretreatment PET/CT-scan (performed two times) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with stage III-IV head and neck cancer
- description
- 18F-EF5 PET/CT scan
- interventionNames
- Drug: 18F-EF5
- Procedure: Pretreatment PET/CT-scan (performed two times)
Primary outcomes (1)
- measure
- Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV)
- timeFrame
- Baseline and 7 days (ie time between the two scans)
- description
- Standardized Uptake Values (SUV) are determined in the acquisition images of the \[18F\]EF5 studies.The difference between the baseline and second SUV is calculated and Bland-Altman plots are generated to compare the group means
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Performance status: Karnofsky score 70 or better or WHO performance status 2 or better * Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck * Primary tumor diameter as determined clinically or from contrast enhanced CT or T1-weighed MRI scan must be at least 15 mm * Patients with nodal neck metastases of head and neck cancer are eligible * Mental status: Patients must be able to understand the meaning of the study * The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff * Patient, if female, must not be pregnant or lactating at the time of the study Exclusion Criteria: * Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease. * Patient must have no history of previous chemotherapy or biological therapy or RT for treatment of head and neck cancer. * Patient must not have an uncontrolled serious infection * Patients with organ metastases in liver, bone, brain or lung.
References
Publications (0)
Data not yet available
No reference posted for this study.