PET/CT imaging of uPAR-expression in patients with neuroendocrine tumors using 68Ga-NOTA-AE105

Phase 1

Conditions: Patients with neuroendocrine tumors (gastro-entero-pancreatic and bronchopulmonary)
MedDRA version: 20.0Level: LLTClassification code 10067518Term: Pancreatic neuroendocrine tumorSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10078184Term: Neuroendocrine tumor of the lung metastaticSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10078183Term: Neuroendocrine tumor of the lungSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10077560Term: Gastroenteropancreatic neuroendocrine tumor diseaseSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10068916Term: Pancreatic neuroendocrine tumor metastaticSystem Organ Class: 100000004864
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2017-002312-13-DK

Lead Sponsor: Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

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

•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-NOTA-AE105
•In case of broncho-pulmonary NET, the subtype must not be small cell lung cancer (SCLC)