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

Rigshospitalet

Status and phase

Completed

Phase 2

Conditions

Neuroendocrine Tumors

Treatments

Device: PET/CT

Drug: One injection of 68Ga-NOTA-AE105

Study type

Interventional

Funder types

Other

Identifiers

NCT03278275

AK2017-1

2017-002312-13 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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)

Enrollment

116 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)