About this trial
The neuroendocrine neoplasms of the small intestine (Si-NENs) is a relatively rare malignancy. Surgical resection is the only curative treatment for the early-stage. It remains controversial its application for advanced metastatic gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
The identification of metastatic disease and tumor grade are the most important prognostic factors in advanced GEPNETs. Therefore, precise staging and evaluation of disease burden with a reliable imaging method is crucial for determining the correct stage of the disease and consequently the correct treatment.
A unique feature of NeuroEndocrinal Tumors (NETs) is the expression of somatostatin receptors (SSTR) which can be targeted with radiolabeled peptides for imaging.
The Positron Emission Tomography-Computed Tomography (PET/CT) technique using somatostatin analogs labeled with the positron emitting isotope, 68Ga (68Ga-DOTA peptides), has been shown to offer advantages over conventional imaging modalities as well as additional important quantitative and qualitative diagnostic information.
The aim of this study is to calculate the sensitivity (SE), the specificity (SP), the positive and negative predictive values (PPV and NPV) and the overall accuracy of 68Ga-DOTATOC PET/CT-enterography in detecting in primary lesion and multifocality of siNETs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with small bowel neuroendocrine tumours
tumors with any grade (from 1 to 3) and any Ki 67 percentage
patients eligible for surgical resection
Disqualifiers
patients with synchronous other oncological disease
patients with Inflammatory bowel disease
patients Not eligible for surgery
Trial design
Single group
Treatments tested in this trial
PET/CT-enterography with 68Ga-DOTATOC
Other interventionPatients underwent to PET/CT-enterography with 68Ga-DOTATOC
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of predictive role of CT-Enterography and 68Ga-DOTATOC PET/CT in detecting siNETs
Proportion of the true positive patients at diagnostic procedure considering the pathology results as the gold standard.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.