Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turku University Hospital

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.