Cancer of Mouth, Head and Neck Neoplasms, Neoplasms, Neoplasms by Site, Oral Cancer, Oropharyngeal Cancer
Conditions
Keywords
Uroplasminogen Plasminogen Activator Receptor, Oropharyngeal cancer, oral cancer, Positron Emission Tomography
Brief summary
uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer
Detailed description
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 +).
Interventions
One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings. | Through study completion, an average of 1.5 year |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the correlation between uPAR PET signal (quantified as SUVmax) and the immunohistochemical expression of uPAR evaluated by an H-score (intensity x the percentage of stained tumor tissues throughout the tumor margin). | Through study completion, an average of 1.5 year |
| Evaluation of the correlation between tumor burden (assessed v.h.a. TNM staging) uPAR-PET signal (assessed as SUVmax) and the amount of uPAR metabolites in plasma. | Through study completion, an average of 1.5 year |
| Determination of the lower detection limit of the amount of tumor tissue for uPAR-PET correlated with the histological H-score x tumor size (where tumor size is evaluated on the pathological preparation of pathologist) | Through study completion, an average of 1.5 year |
Countries
Denmark
Outcome results
None listed