Diagnosis and follow up of neuroendocrine tumours with PET/CT

Conditions: euroendocrine tumors
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2013-000370-30-SE

Lead Sponsor: orrlands University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Age < 18 years

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Comparison with CT and MR for evaluation of accuracy.<br>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 Outcome Measures