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

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159920
• Other study ID #: PET-NET-Retrospective
• Status: Recruiting
• Start date: October 27, 2021
• Est. completion date: December 27, 2024

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: Arturo Chiti
• Phone: 0226432716
• Email: chiti.arturo[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 27, 2024
• Est. primary completion date: December 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Diagnostic Test:
• diagnostic accuracy
The aim of this retrospective study is to evaluate the diagnostic and prognostic value of PET/MRI and PET/CT with the use of different radiopharmaceuticals (68Ga-DOTATOC -edotreotide, and 18F-FDG - fluorodeoxyglucose) for the study of patients suffering from neuroendocrine tumors. To this end, both traditional imaging parameters and the contribution of radiomic features will be investigated. The latter are quantitative features extracted from biomedical images, and are believed to be able to provide information, otherwise impossible to investigate, useful for the characterization of various pathologies.

Locations

Country	Name	City	State
Italy	Irccs San Raffaele	Milano	Italia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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