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

Phase 2

Completed

• Conditions: Neuroendocrine Tumors
• Interventions: Drug: One injection of 68Ga-NOTA-AE105; Device: PET/CT

• Registration Number: NCT03278275
• Lead Sponsor: Rigshospitalet, Denmark

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)

Study Timeline

• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Study Start: 2017-11-01
• Primary Completion: 2021-07-08
• Study Completion: 2021-07-08
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
uPAR PET/CT	One injection of 68Ga-NOTA-AE105	One injection of the radioligand 68Ga-NOTA-AE105
uPAR PET/CT	PET/CT	One injection of the radioligand 68Ga-NOTA-AE105

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet; 🇩🇰 Copenhagen, Denmark