Neuroendocrine Tumors
Conditions
Keywords
68Ga-NODAGA-E[c(RGDyK)]2, Angiogenesis PET/CT, Neuroendocrine tumors
Brief 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).
Interventions
One injection of 68Ga-NODAGA-E\[c(RGDyK)\]2
DEVICEPET/CT
Following injection of 68Ga-NODAGA-E\[c(RGDyK)\]2 the patients will be subjected to whole body PET/CT
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with gastro-entero-pancreatic Neuroendocrine Tumors (GEP-NET; grade: G1-G3) or broncho-pulmonary NET. * WHO performance status 0-2 * Must be able to read and understand the patient information in Danish and to give informed consent
Exclusion criteria
* Pregnancy * Breast-feeding * Weight more than the maximum weight limit for the PET/CT bed of the scanner (140 kg) * History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E\[c(RGDyK)\]2 * In case of broncho-pulmonary NET, the subtype must not be small cell lung cancer (SCLC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angiogenesis PET/CT imaging of patients with neuroendocrine tumors | 1 hour | The radioligand 68Ga-NODAGA-E\[c(RGDyK)\]2 can be used to visualize neuroendocrine tumors (grade G1-G3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiogenesis PET/CT progonostic factor for progression free survival | 12 months | 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) |
| Angiogenesis PET/CT prognostic factor for overall and disease specific survival | 12 months | 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) |
| Target validation of angiogenesis PET/CT | 2 weeks | 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) |
Countries
Denmark
Outcome results
None listed