Peroperative Assessment of Malignancies of the Head and Neck Using High-resolution 18F-FDG-PET/CT

Peroperative Assessment of Tumour Resection Margins Using High-resolution 18F-FDG-PET/CT in Malignancies of the Head and Neck, a Pilot Study

In this study, patients diagnosed with a pathology-proven malignancy of the head and neck will receive a routine clinical activity of 18F-FDG ((18)F-luorodeoxyglucose) before undergoing standard of care surgical resection of the malignancy. Following the resection, the 18F-FDG-infused malignancy will be investigated utilizing a novel high-resolution Positron Emission Tomography (PET) and Computed Tomography (CT) scan. Slicing of the malignancy will be followed by additional PET/CT-scanning and autoradiography of the sliced specimen. The results found during image analysis will be compared to the results of the gold standard of histopathology. As this is no approved way of assessing the tumour's margin, the conclusion of the scan will not be used as a method for changing the patients' treatment.

Inclusion Criteria:

• Patients with one or multiple pathologically proven malignancies in the head and neck region (targeted lesions), independent of origin and stage.
• Patient is planned for the surgical resection of the targeted lesion.
• Age ≥ 18 years.
• Karnofsky performance scale ≥30
• Patient has given informed consent according to the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines in accordance with the declaration of Helsinki.

Exclusion Criteria:

• Patient is planned for a treatment regimen which does not include standard surgical resection of the targeted lesion.
• Pregnant or actively lactating women.
• Blood glucose level ≥ 200mg/dl or more on the day of surgery.