Neuroendocrine tumour
Conditions
Interventions
Product Name: 68Ga-DOTATOC
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: OCTREOTIDE
CAS Number: 83150-76-9
Other descriptive name: 68Ga-1,4,7,10-tetraazacyclo-dodecane-1,4,
Sponsors
Karolinska University Hospital Solna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with neueoendocrine tumour in need of somatostatin receptor imaging for staging of the disease, depiction of the primary tumour and patients with medullary thyroid cancer in need for pre-operative lymph node mapping. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: Age less than 18 years Claustrofobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is an exploratory observational Phase II trial to investigate the imaging capacity of 68Ga-DOTATOC-PET/CT in patients with neuroendocrine tumours and medullary thyroid cancer in comparison with either Whole-Body-Magnetic Resonance Imaging using Diffusion Weighted Signal sequences (DWI-MRI) and in comparison with conventional radiological procedures such as CT and US and long term follow-up.;Secondary Objective: There are no secondary endpoints in this trial;Primary end point(s): When both PET/CT and WB-MRI has been performed and compared and correlated to findings at surgery, histopathology and radiological and clinical follow-up;Timepoint(s) of evaluation of this end point: Varying, because some patients undergo surgery and histopathology immediately after PET/CT and MRI and others needs to be followed radiological and clinically for longer time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: There are no secondary endpoints in this trial;Secondary end point(s): There are no secondary endpoints in this trial | — |
Countries
Sweden
Contacts
Public ContactDept. Nuclear Medicine
Karolinska University Hospital
Outcome results
None listed