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Clinical Trials in Italy / NCT06773624
Recruiting Not applicable

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

NCT06773624 · tracked via the Priya Life Science Italy tracker
Sponsor
European Institute of Oncology
Phase
Not applicable
Started
2021-04-23
Last updated
2025-01-14

Condition(s) studied

Small Bowel NeoplasiaNeuroendocrine (NE) Tumors

Investigational drug(s) / intervention(s)

PET/CT-enterography with 68Ga-DOTATOC

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06773624 on ClinicalTrials.gov ↗ ← All trials in Italy