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Recruiting NCT06773624

Use of 68Ga-DOTATOC PET/CT-enterography for Detection of the Primary Lesion in Neuroendocrine Tumors of the Small Bowel

No phase Interventional Small Bowel Neoplasia Neuroendocrine (NE) Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PET/CT-enterography with 68Ga-DOTATOC.
Who it may be relevant to
Registry conditions: Small Bowel Neoplasia, Neuroendocrine (NE) Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of 68Ga-DOTATOC PET/CT-enterography for the Detection of the Primary Lesion in Neuroendocrine Tumors of the Small Bowel

Overview

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.

Interventions

  • Other PET/CT-enterography with 68Ga-DOTATOC
    Patients underwent to PET/CT-enterography with 68Ga-DOTATOC

Primary outcome measures

  • Evaluation of predictive role of CT-Enterography and 68Ga-DOTATOC PET/CT in detecting siNETs [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • patients with small bowel neuroendocrine tumours
  • tumors with any grade (from 1 to 3) and any Ki 67 percentage
  • patients eligible for surgical resection

Exclusion criteria

  • patients with synchronous other oncological disease
  • patients with Inflammatory bowel disease
  • patients Not eligible for surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Italy · 1 center
  • European Institute of Oncology — Milan

Identifiers

NCT: NCT06773624 · IEO 1441

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗