PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

Official Title
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PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105

Conditions
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Neuroendocrine Tumors

Intervention / Treatment
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* Drug: One injection of 68Ga-NOTA-AE105
* Device: PET/CT


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: uPAR PET/CT<br>One injection of the radioligand 68Ga-NOTA-AE105 | Drug: One injection of 68Ga-NOTA-AE105<br>* One injection of 68Ga-NORA-AE105<br>Device: PET/CT<br>* Following injection of 68Ga-NOTA-AE105 the participants will be subjected to whole body PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urokinase plasminogen activator receptor, uPAR PET/CT, positron emission tomography, neuroendocrine tumors