PET/CT imaging of angiogenesis in patients with neuroendocrine tumors using 68Ga-NODAGA-E[c(RGDyK)]2

PET/CT imaging of angiogenesis in patients with neuroendocrine tumors using 68Ga-NODAGA-E[c(RGDyK)]2 - PET/CT imaging of angiogenesis in patients with neuroendocrine tumors using 68Ga-NODAGA-E[c(RGDyK)]2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002512-14-DK

Enrollment

120

Registered

2017-07-06

Start date

2017-09-04

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with neuroendocrine tumors (gastro-entero-pancreatic and bronchopulmonary) MedDRA version: 20.0 Level: LLT Classification code 10067518 Term: Pancreatic neuroendocrine tumor System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10078184 Term: Neuroendocrine tumor of the lung metastatic System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10078183 Term: Neuroendocrine tumor of the lung System Organ Class: 100000004864 Med

Interventions

Product Name: 68Ga-NODAGA-E[c(RGDyK)]2 Product Code: 68Ga-NODAGA-E[c(RGDyK)]2 Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: 68Ga-NODAGA-E[c(RG

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age > 18 years • Diagnosed with gastro-enetero-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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

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
Main Objective: In this study with angiogenesis PET we include patients diagnosed with neuroendocrine tumors in order to investigate the diagnostic performance of angiogenesis PET ;Secondary Objective: The prognostic value of angiogenesis PET for predicting progression free survival, disease specific survival and overall survival. An angiogenesis PET will be performed as a baseline scan and the patients will be followed for 12 months;Primary end point(s): Angiogenesis PET/CT with the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 can be used to visualize neuroendocrine tumors (grade G1-G3);Timepoint(s) of evaluation of this end point: Uptake of the radioligand in tumor lesions from angiogenesis PET performed 45 minutes post injection of 68Ga-NODAGA-E[c(RGDyK)]2	—

Measure

Time frame

Main Objective: In this study with angiogenesis PET we include patients diagnosed with neuroendocrine tumors in order to investigate the diagnostic performance of angiogenesis PET ;Secondary Objective: The prognostic value of angiogenesis PET for predicting progression free survival, disease specific survival and overall survival. An angiogenesis PET will be performed as a baseline scan and the patients will be followed for 12 months;Primary end point(s): Angiogenesis PET/CT with the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 can be used to visualize neuroendocrine tumors (grade G1-G3);Timepoint(s) of evaluation of this end point: Uptake of the radioligand in tumor lesions from angiogenesis PET performed 45 minutes post injection of 68Ga-NODAGA-E[c(RGDyK)]2

—

Secondary

Measure	Time frame
Secondary end point(s): Prognostic information (correlation of 68Ga-NODAGA-E[c(RGDyK)]2 uptake in tumor lesions) and 1. progression free survival 2. disease specific survival 3. overall survival;Timepoint(s) of evaluation of this end point: 1. Progression free survival : 12 months 2. Disease specific survival: 6 months 3. Overall survival: 12 months	—

Countries

Denmark

Contacts

Public ContactDorthe Skovgaard

Rigshospitalet, Copenhagen University Hospital

dorthe.skovgaard@regionh.dk004535454011

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026