NCT03271281

PET/CT Imaging of Angiogenesis in Patients With Neuroendocrine Tumors Using 68Ga-NODAGA-E[c(RGDyK)]2

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (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 angiogenesis PET/CT with the radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 in patients with neuroendocrine tumors (NETs).

Detailed description

The radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 targets the Arg-Gly-Asp (RGD) sequence known to bind with the αvβ3 integrin that is expressed on the surface of angiogenic blood vessels or tumor cells. The radioligand can be used to visualize tumor angiogenesis using PET/CT. A total of 120 NET patients will be subjected to an angiogenesis-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-NODAGA-E\[c(RGDyK)\]2 (Standardized Uptake Values, SUVmax) 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-NODAGA-E[c(RGDyK)]2	One injection of 68Ga-NODAGA-E\[c(RGDyK)\]2
DEVICE	PET/CT	Following injection of 68Ga-NODAGA-E\[c(RGDyK)\]2 the patients will be subjected to whole body PET/CT

Timeline

• Start date: 2017-12-04
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2017-09-05
• Last updated: 2022-06-30

Locations

1 site across 1 country: Denmark