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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002312-13 | EudraCT Number |
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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).
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| uPAR PET/CT | Experimental | One injection of the radioligand 68Ga-NOTA-AE105 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One injection of 68Ga-NOTA-AE105 | Drug | One injection of 68Ga-NORA-AE105 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| uPAR PET/CT imaging of patients with neuroendocrine tumors | The radioligand 68Ga-NOTA-AE105 can be used to visualize neuroendocrine tumors (grade G1-G3) | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| uPAR PET/CT prognostic factor for progression free survival | The uptake of the 68Ga-NOTA-AE105 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with progression free survival (PFS) neuroendocrine tumors (grade G1-G3) | 12 months |
| uPAR 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 | 2100 | 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-NOTA-AE105 the participants will be subjected to whole body PET/CT |
|
The uptake of the 68Ga-NOTA-AE105 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 |
| 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 |