PET/CT imaging of angiogenesis in patients with neuroendocrine tumors using 68Ga-NODAGA-E[c(RGDyK)]2
- Conditions
- Patients with neuroendocrine tumors (gastro-entero-pancreatic and bronchopulmonary)MedDRA version: 20.0Level: LLTClassification code 10067518Term: Pancreatic neuroendocrine tumorSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10078184Term: Neuroendocrine tumor of the lung metastaticSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10078183Term: Neuroendocrine tumor of the lungSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10077560Term: Gastroenteropancreatic neuroendocrine tumor diseaseSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10068916Term: Pancreatic neuroendocrine tumor metastaticSystem Organ Class: 100000004864Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2017-002512-14-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
•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
•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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Prognostic information (correlation of 68Ga-NODAGA-E[c(RGDyK)]2 uptake in tumor lesions) and<br>1. progression free survival<br>2. disease specific survival<br>3. overall survival;Timepoint(s) of evaluation of this end point: 1. Progression free survival : 12 months<br>2. Disease specific survival: 6 months<br>3. Overall survival: 12 months