Neuroendocrine Tumors
Conditions
Keywords
urokinase plasminogen activator receptor, uPAR PET/CT, positron emission tomography, neuroendocrine tumors
Brief summary
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
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)
Interventions
One injection of 68Ga-NORA-AE105
DEVICEPET/CT
Following injection of 68Ga-NOTA-AE105 the participants 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 |
|---|---|---|
| uPAR PET/CT imaging of patients with neuroendocrine tumors | 1 hour | The radioligand 68Ga-NOTA-AE105 can be used to visualize neuroendocrine tumors (grade G1-G3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| uPAR PET/CT prognostic factor for progression free survival | 12 months | 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) |
| uPAR PET/CT prognostic factor for overall and disease specific survival | 12 months | 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) |
Countries
Denmark
Outcome results
None listed