Neuroendocrine tumors
Conditions
Interventions
Product Name: 68Ga-DotaToc
Pharmaceutical Form: Solution for injection/infusion
Sponsors
Norrlands University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with high suspicion of or with known neuroendocrine tumors are included and a base-line PET/CT is done for staging and depiction of the primary tumor is done. Patients with known neuroendocrine tumors with suspected recurrence is included and a PET/CT is done for evaluation. Patients with an accidentally diagnosed neuroendocrine tumor at surgery for other diagnoses are included after primary surgery and a PET/CT is done for staging. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Age < 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This trial aim to evaluate the diagnostic and prognostic value of 68Ga-Dota-TOC in patients with neuroendocrine tumors. The findings will be compared with conventional imaging such as computed tomography (CT), magnetic resonance imaging (MR) as well as with biomarkers (Ki-67) and histopathology. All patients will undergo long term follow up. ;Secondary Objective: Not applicable;Primary end point(s): Correlation to surgery results, histopathology and biomarkers when possible. Comparison with CT and MR for evaluation of accuracy. Quantification of uptakes of 68Ga-Dota-Toc at each examination and changes over time to correlate with disease development;Timepoint(s) of evaluation of this end point: Varying due to clinical course of the disease. A base-line scan is intended before treatment start. The time to surgery differ due to other treatment possibilities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Sweden
Contacts
Public ContactKatrine Åhlström Riklund
Norrlands University Hospital
Outcome results
None listed