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

Study Overview
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Brief Summary
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uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer

Detailed Description
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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 +).

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

Conditions
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Oral Cancer, Oropharyngeal Cancer, Neoplasms, Head and Neck Neoplasms, Cancer of Mouth, Neoplasms by Site

Intervention / Treatment
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* Other: 68Ga-NOTA-AE105 PET/CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-NOTA-AE105 PET/CT<br>One injection of 68Ga-NOTA-AE105 followed by positron emission tomography/computed tomography (PET/CT scan) will be performed before surgery and compared with the histological findings to evaluate uPAR PET/CT in staging of oral cancer and oropharyngeal cancer. | Other: 68Ga-NOTA-AE105 PET/CT<br>* One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uroplasminogen Plasminogen Activator Receptor, Oropharyngeal cancer, oral cancer, Positron Emission Tomography