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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
113
One injection of 68Ga-NODAGA-E\[c(RGDyK)\]2
Following injection of 68Ga-NODAGA-E\[c(RGDyK)\]2 the patients will be subjected to whole body PET/CT
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, Denmark
Angiogenesis PET/CT imaging of patients with neuroendocrine tumors
The radioligand 68Ga-NODAGA-E\[c(RGDyK)\]2 can be used to visualize neuroendocrine tumors (grade G1-G3)
Time frame: 1 hour
Angiogenesis PET/CT progonostic factor for progression free survival
The uptake of the 68Ga-NODAGA-E\[c(RGDyK)\]2 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with progression free survival (PFS) neuroendocrine tumors (grade G1-G3)
Time frame: 12 months
Angiogenesis PET/CT prognostic factor for overall and disease specific survival
The uptake of the 68Ga-NODAGA-E\[c(RGDyK)\]2 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with overall and disease specific free survival (PFS) neuroendocrine tumors (grade G1-G3)
Time frame: 12 months
Target validation of angiogenesis PET/CT
Uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 correlates directly to gene expression of angiogenesis markers αvβ3 integrin and VEGF-A in tumor tissue obtained by biopsies or planned surgery (\<2 weeks before/after angiogenesis PET/CT)
Time frame: 2 weeks
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