Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06773624

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Small Bowel Neoplasia Neoplasms Neuroendocrine (NE) Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET/CT-enterography with 68Ga-DOTATOC

Other

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

Primary outcomes

  1. Evaluation of predictive role of CT-Enterography and 68Ga-DOTATOC PET/CT in detecting siNETs

    Time frame: 3 months

    Proportion of the true positive patients at diagnostic procedure considering the pathology results as the gold standard.

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi Funicelli, MD

CONTACT

[email protected]

+390294372725

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.