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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002512-14 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Angiogenesis PET/CT | Experimental | One injection of the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 followed by PET/CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One injection of 68Ga-NODAGA-E[c(RGDyK)]2 | Drug | One injection of 68Ga-NODAGA-E[c(RGDyK)]2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| Angiogenesis PET/CT prognostic factor for overall and disease specific survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esben Carlsen, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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| PET/CT | Device | Following injection of 68Ga-NODAGA-E[c(RGDyK)]2 the patients will be subjected to whole body PET/CT |
|
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) |
| 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) | 2 weeks |
| D009380 | Neoplasms, Nerve Tissue |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |