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

NCT06773624 | Recruiting

• 1 other identifier: IEO 1441
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Bowel Neoplasia; Neuroendocrine (NE) Tumors

Outcome Measures

Primary Outcomes (1)

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

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

  3 months

Study Arms (1)

PET/CT-enterography with 68Ga-DOTATOC

OTHER

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

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

Interventions

PET/CT-enterography with 68Ga-DOTATOC OTHER

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

PET/CT-enterography with 68Ga-DOTATOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Ga(III)-DOTATOC

Central Study Contacts

Luigi Funicelli, MD

CONTACT

+390294372725; luigi.funicelli@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: April 23, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)