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

Rigshospitalet

Status and phase: Completed; Phase 2

Conditions: Neuroendocrine Tumors

Treatments: Drug: One injection of 68Ga-NODAGA-E[c(RGDyK)]2; Device: PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03271281

2017-002512-14 (EudraCT Number)

AK2017-2

Details and patient eligibility

About

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).

Full 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).

Enrollment: 113 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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

113 participants in 1 patient group

Experimental: Angiogenesis PET/CT

Experimental group

Description:

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

Treatment:

Device: PET/CT

Drug: One injection of 68Ga-NODAGA-E[c(RGDyK)]2