PET/CT Imaging of Angiogenesis in Patients With Neuroendocrine Tumors Using 68Ga-NODAGA-E[c(RGDyK)]2

Phase 2

Completed

• Conditions: Neuroendocrine Tumors
• Interventions: Drug: One injection of 68Ga-NODAGA-E[c(RGDyK)]2; Device: PET/CT

• Registration Number: NCT03271281
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of angiogenesis PET/CT with the radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 in patients with neuroendocrine tumors (NETs).

Detailed Description

The radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 targets the Arg-Gly-Asp (RGD) sequence known to bind with the αvβ3 integrin that is expressed on the surface of angiogenic blood vessels or tumor cells. The radioligand can be used to visualize tumor angiogenesis using PET/CT.

A total of 120 NET patients will be subjected to an angiogenesis-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-NODAGA-E\[c(RGDyK)\]2 (Standardized Uptake Values, SUVmax) 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: 2017-08-31
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-05
• Study Start: 2017-12-04
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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
Experimental: Angiogenesis PET/CT	One injection of 68Ga-NODAGA-E[c(RGDyK)]2	One injection of the radioligand 68Ga-NODAGA-E\[c(RGDyK)\]2 followed by PET/CT
Experimental: Angiogenesis PET/CT	PET/CT	One injection of the radioligand 68Ga-NODAGA-E\[c(RGDyK)\]2 followed by PET/CT

Primary Outcome Measures

Name	Time	Method
Angiogenesis PET/CT imaging of patients with neuroendocrine tumors	1 hour	The radioligand 68Ga-NODAGA-E\[c(RGDyK)\]2 can be used to visualize neuroendocrine tumors (grade G1-G3)

Secondary Outcome Measures

Name	Time	Method
Angiogenesis PET/CT progonostic factor for progression free survival	12 months	The uptake of the 68Ga-NODAGA-E\[c(RGDyK)\]2 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with progression free survival (PFS) neuroendocrine tumors (grade G1-G3)
Angiogenesis PET/CT prognostic factor for overall and disease specific survival	12 months	The uptake of the 68Ga-NODAGA-E\[c(RGDyK)\]2 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with overall and disease specific free survival (PFS) neuroendocrine tumors (grade G1-G3)
Target validation of angiogenesis PET/CT	2 weeks	Uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 correlates directly to gene expression of angiogenesis markers αvβ3 integrin and VEGF-A in tumor tissue obtained by biopsies or planned surgery (\<2 weeks before/after angiogenesis PET/CT)

Trial Locations

Locations (1)

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