Neuroendocrine neoplasms MedDRA version: 21.0 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10057270 Term: Neuroendocrine carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10068916 Term: Pancreatic neuroendocrine tu
Conditions
Interventions
Trade Name: Fluor-18-FDG, solution for injection
Pharmaceutical Form: Injection
INN or Proposed INN: FLUDEOXYGLUCOSE (18F)
CAS Number: 105851-17-0
Concentration unit: MBq megabecquerel(s)
Concentratio
Sponsors
Department of Clinical Physiology and Nuclear Medicine, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age of or above 18 years 2) Histopathologically verified gastro-pancreatic neuroendocrine neoplasm 3) Patients with unknown primary tumor with metastases with verified neuroendocrine neoplasm positive histopathological examination suggesting gastro-pancreatic origin 4) Must be able to read and understand the patient information in Danish and to give informed consent 5) WHO Performance status 0-2 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1) Pregnancy 2) Breast-feeding 3) Weights more than the maximum weight limit for the PET/CT bed of the scanner (140 kg) 4) Uncontrolled diabetes 5) Uncontrolled infection 6) Exacerbation in autoimmune diseases 7) Other active cancer disease 8) Conditions or diseases (e.g. uncontrolled Parkinson’s disease) making the patient unable to lie still in the scanner 9) Severe claustrophobia 10) Localized neuroendocrine neoplasms of the appendix, the rectum measuring < 1 cm, and ECL-omas of the stomach 11) History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18FDG or 64Cu-DOTATATE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if Cox proportional hazard models based on tumor standardized uptake values and tumor volume measurements from 18FDG PET/CT and 64Cu-DOTATATE PET/CT are both prognostic of progression free survival and overall survival; and if Cox proportional hazard models based on tumor standardized uptake values and tumor volume measurements derived from combined 18FDG and 64Cu-DOTATATE PET/CT provide stronger prognostic information than 18FDG PET/CT or 64Cu-DOTATATE PET/CT alone. ;Secondary Objective: To investigate if standardized uptake values from manually depicted regions-of-interests, semi-automatic segmentation methods, and machine-learning based algorithms on 64Cu-DOTATATE PET correlate inversely with corresponding tumor SUVs on 18FDG PET.;Primary end point(s): Overall survival (OS) and progression free survival (PFS). ;Timepoint(s) of evaluation of this end point: 12 months following the last patient's last visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The correlation between of 18FDG and 64Cu-DOTATATE standardized uptake values from tumors and healthy tissues derived from manually depicted regions-of-interests, semi-automatic segmentation methods and machine-learning based algorithms.;Timepoint(s) of evaluation of this end point: When data from dual 18FDG and 64Cu-DOTATATE PET/CT are available from 50 patients. | — |
Countries
Denmark
Contacts
Public ContactMathias Loft
Department of Clinical Physiology and Nuclear Medicine, Rigshospitalet
Outcome results
None listed