Diagnostic Performance and Quantitative Analysis of [18F]FET PET in Brain Tumours

NCT07599917 | Not Yet Recruiting

• 1 other identifier: FET-BRAIN-DX
• Study Type: observational
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Brain Tumors

Keywords

FET PET; Brain Tumors; Meningioma; Diagnostic Accuracy; Dynamic PET Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Secondary Outcome Measure

  Up to December 31, 2025.

• Diagnostic Outcome Measure

  Up to December 31, 2025.

• Quantitative outcome

  Up to December 31, 2025.

• Secondary Outcome Measure

  Up to December 31, 2025

• Secondary Outcome Measure

  Up to December 31, 2025.

Study Arms (1)

Patients with brain tumors

Patients with gliomas, brain metastases and meningiomas

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy or breastfeeding

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Brain Neoplasms; Meningioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Central Study Contacts

Chiara Catalano, PhD

CONTACT

+39 0226433639; catalano.chiara@hsr.it; ricercamednuc@hsr.it

Alexandra Lazar, Dr.

CONTACT

lazar.alexandra@hsr.it;

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Unit of Nuclear Medicine, IRCCS San Raffaele Hospita

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05