Clinical Trial: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase II Trial: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
Brief Summary: uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer
Detailed Summary:
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 +).
Sponsor: Rigshospitalet, Denmark
Current Primary Outcome: The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings. [ Time Frame: Through study completion, an average of 1.5 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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). [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: Through study completion, an average of 1.5 year ]
Original Secondary Outcome: Same as current
Information By: Rigshospitalet, Denmark
Dates:
Date Received: October 11, 2016
Date Started: November 2016
Date Completion: August 2018
Last Updated: November 7, 2016
Last Verified: November 2016