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

European Institute of Oncology

Status: Enrolling

Conditions: Small Bowel Neoplasia; Neuroendocrine (NE) Tumors

Treatments: Other: PET/CT-enterography with 68Ga-DOTATOC

Study type: Interventional

Funder types: Other

Identifiers

NCT06773624

IEO 1441

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

PET/CT-enterography with 68Ga-DOTATOC

Other group

Description:

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

Treatment:

Other: PET/CT-enterography with 68Ga-DOTATOC