NCT03278275

PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of uPAR PET/CT with the radioligand 68Ga-NOTA-AE105 in patients with neuroendocrine tumors (NETs).

Detailed description

68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. A total of 120 NET patients will be subjected to a uPAR-PET/CT scan. Follow-up will be performed (from the time of the angiogenesis PET/ CT) at 6 months for disease specific survival (DSS) and a 1 year follow-up for PFS and OS. The uptake of 68Ga-NOTA-AE105 in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier)

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	One injection of 68Ga-NOTA-AE105	One injection of 68Ga-NORA-AE105
DEVICE	PET/CT	Following injection of 68Ga-NOTA-AE105 the participants will be subjected to whole body PET/CT

Timeline

• Start date: 2017-11-01
• Primary completion: 2021-07-08
• Completion: 2021-07-08
• First posted: 2017-09-11
• Last updated: 2022-06-30

Locations

1 site across 1 country: Denmark