Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Neuroendocrin Tumors.

Neuroendocrine tumors (NETs) constitute approximately 0.5% of malignancies. To date, diagnosis at an increasingly early stage of the disease is possible thanks to recent technological advances in biomedical imaging. In particular, the traditional work-up for these pathologies includes endoscopy, magnetic resonance imaging (MRI) and computed tomography (CT). Furthermore, the integrated positron emission tomography methods (PET/CT and PET/MRI) are innovative molecular imaging techniques and represent a continually expanding field of research in the oncology setting. In particular, PET is taking on an increasingly relevant role for the study of neuroendocrine tumors, also thanks to the introduction of increasingly accurate radiopharmaceuticals (targeted towards somatostatin receptors), thus opening the way to new possibilities for the diagnosis andcharacterization of these tumors, is in the staging and restaging phase .

Study Overview

• Status: Recruiting
• Conditions: Neuroendocrine Tumors
• Intervention / Treatment: Diagnostic test: diagnostic accuracy

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Arturo Chiti; Phone Number: 0226432716; Email: chiti.arturo@hsr.it
• Study Contact Backup: Name: Alessandra Maielli; Phone Number: 0226432716; Email: maielli.alessandra@hsr.it

Study Locations

• Italy
  • Italia
    • Milano, Italia, Italy
      • Recruiting
      • IRCCS San Raffaele
      • Contact: Alessandra Maielli; Phone Number: 0226432716; Email: maielli.alessandra@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

In this study, adult patients suffering from neuroendocrine tumors who have undergone PET examination (PET/CT or PET/MRI) with 18F-FDG or 68Ga-DOTATOC at the U.0 of Nuclear medicine at the RCCS San Raffaele will be considered for clinical reasons both in the staging and restaging phases.

Description

Inclusion Criteria:

• Adult patients affected by neuroendocrine tumors; Patients who have performed at least one PET study with 18F-FDG and/or 68Ga- DOTATOC for the staging or diagnosis of their pathology.

Exclusion Criteria:

• Patients < 18 years old;
• Lack of availability of clinical data and PET imaging useful for analyses.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
800 patients suffering from neuroendocrine tumors who have undergone PET examination (PET/CT or PET/MRI) with 18F-FDG or 68Ga-DOTATOC.	The integrated positron emission tomography methods (PET/CT and PET/MRI) are innovative molecular imaging techniques, for the diagnosis and characterization of these tumors.	2 years

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Estimated): December 27, 2024
• Study Completion (Estimated): December 27, 2024

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: PET-NET-Retrospective

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No