NCT02960724

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 +).

Conditions

• Oral Cancer
• Oropharyngeal Cancer
• Neoplasms
• Head and Neck Neoplasms
• Cancer of Mouth
• Neoplasms by Site

Interventions

Type	Name	Description
OTHER	68Ga-NOTA-AE105 PET/CT	One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2016-11-10
• Last updated: 2016-11-10

Locations

1 site across 1 country: Denmark