Diagnostic Performance and Quantitative Analysis of [18F]FET PET in Brain Tumours (FET-BRAIN-DX)

This is a retrospective study encompassing all [18F]FET PET scans performed at our centre. By analysing both static and dynamic scans, conducting in-depth kinetic modelling, and comparing quantitative parameters across different tumour types and clinical contexts, the study aims to determine the true diagnostic value of [18F]FET PET in everyday clinical practice. The ultimate goal is to identify imaging biomarkers useful for improving tumour characterisation and distinguishing recurrence from post-treatment changes, thereby strengthening the role of [18F]FET PET in modern neuro-oncology.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Tumors

• Study Type: Observational
• Enrollment (Estimated): 69

Contacts and Locations

• Study Contact: Name: Chiara Catalano, PhD; Phone Number: +39 0226433639; Email: catalano.chiara@hsr.it; ricercamednuc@hsr.it
• Study Contact Backup: Name: Alexandra Lazar, Dr.; Email: lazar.alexandra@hsr.it

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) who underwent clinically indicated [18F]FET PET/CT or PET/MR brain scans for evaluation of primary or metastatic brain tumors, including diagnosis, grading, treatment response assessment, or suspected recurrence.

Description

Inclusion Criteria:

• Patients who underwent a brain PET/CT or PET/MRI scan with [18F]FET for clinical reasons during the study period.
• Age ≥ 18 years.
• Indication for the scan related to diagnosis, grading, assessment of treatment response or suspected recurrence of any brain tumour (primary or metastatic).
• Availability of the corresponding static and dynamic images.
• Signed informed consent.

Exclusion Criteria:

• . Pregnancy or breastfeeding

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with brain tumors; Patients with gliomas, brain metastases and meningiomas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	Diagnostic accuracy of [18F]FET PET (static and dynamic PET/CT or PET/MR) in differentiating tumor recurrence from treatment-related changes, using a composite reference standard including histopathological data (when available) and clinical-radiological follow-up.	Retrospective analysis of data acquired up to December 31, 2025.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome Measure	Quantification and clinical utility of static [18F]FET PET parameters in tumor characterization.	Up to December 31, 2025.
Diagnostic Outcome Measure	Diagnostic performance of quantitative [18F]FET PET parameters in differentiating tumor types and clinical categories (high-grade vs low-grade gliomas, primary brain tumors vs metastases, and histological subtypes).	Up to December 31, 2025.
Quantitative outcome	Correlation of quantitative [18F]FET PET metrics with imaging biomarkers from other modalities and added value of kinetic modeling.	Up to December 31, 2025.
Secondary Outcome Measure	Quantification and clinical utility of dynamic [18F]FET PET parameters in tumor characterization	Up to December 31, 2025
Secondary Outcome Measure	Quantification and clinical utility of kinetic and parametric [18F]FET PET in tumor characterization	Up to December 31, 2025.

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Brain Tumors; Diagnostic Accuracy; Meningioma; FET PET; Dynamic PET Imaging
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Meningioma; Brain Neoplasms
• Other Study ID Numbers: FET-BRAIN-DX

Drug and device information, study documents

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