uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
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|ClinicalTrials.gov Identifier: NCT02960724|
Recruitment Status : Unknown
Verified November 2016 by Kirstine Karnov, Rigshospitalet, Denmark.
Recruitment status was: Recruiting
First Posted : November 10, 2016
Last Update Posted : November 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Oral Cancer Oropharyngeal Cancer Neoplasms Head and Neck Neoplasms Cancer of Mouth Neoplasms by Site||Other: 68Ga-NOTA-AE105 PET/CT||Phase 2|
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:
Patients with oral cancer without clinical evidence of spread (OSCC in stage cN0)
Patients with metastatic oral cancer (OSCC in stage cN +) and patients with metastatic oropharyngeal cancer (OPSCC in stage cN +).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: 68Ga-NOTA-AE105 PET/CT
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
One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960724
|Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Kirstine KS Karnovs, MD +4526227128 Kirstine.email@example.com|
|Contact: Andreas Kjær, MD,DMSc,PhD +4535454011 firstname.lastname@example.org|
|Study Director:||Andreas Kjær, MD,DMSc,PhD||Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet|