Phase 2
Completed N=10
Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
Source: ClinicalTrials.gov NCT01774760 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV) — 1.49 SUVmax
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV) |
1.49 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01774760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.