uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer

Phase II Trial: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer

uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer

To compare the diagnostic value of uPAR-PET/CT for prognostication compared to the current imaging options (CT, MRI and ultrasound) by observer-blinded readings. The reference that will be used as "gold standard" is the pathological examination of the surgically removed tissues.

The new imaging modality (uPAR-PET/CT) will be used in two separate groups of patients with head and neck cancer:

Study I:

Patients with oral cancer without clinical evidence of spread (OSCC in stage cN0)

Study II:

Patients with metastatic oral cancer (OSCC in stage cN +) and patients with metastatic oropharyngeal cancer (OPSCC in stage cN +).

Inclusion Criteria:

• Able to understand patient information and to give informed consent
• Not previously irradiated or operated on neck
• Operable disease

Study I OSCC cN0 verified histologically by pathologic examination of biopsy

Study II OSCC or OPSCC N + verified histologically by pathologic examination of biopsy

Exclusion Criteria:

• Pregnancy
• Patients who are candidates for curative intentional radiation
• Patients who have had surgery or radiation therapy to the neck as this may alter the lymph drainage.
• Other diseases assessed by the investigator as basis for exclusion.
• Age under 18 or over 85 years
• Obesity> 140 kg
• Allergy to 68Ga-NOTA-AE105