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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06773624

Enrollment

Registered

2025-01-14

Start date

2021-04-23

Completion date

2026-12-31

Last updated

2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine (NE) Tumors, Small Bowel Neoplasia

Brief summary

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

OTHERPET/CT-enterography with 68Ga-DOTATOC

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of predictive role of CT-Enterography and 68Ga-DOTATOC PET/CT in detecting siNETs	3 months	Proportion of the true positive patients at diagnostic procedure considering the pathology results as the gold standard.

Countries

Italy

Contacts

Primary ContactLuigi Funicelli, MD

luigi.funicelli@ieo.it+390294372725

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026