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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07599917

Acronym

FET-BRAIN-DX

Enrollment

Registered

2026-05-20

Start date

2026-06-01

Completion date

2026-12-31

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumors

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary outcome	Retrospective analysis of data acquired up to December 31, 2025.	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.

Secondary

Measure	Time frame	Description
Secondary Outcome Measure	Up to December 31, 2025.	Quantification and clinical utility of static \[18F\]FET PET parameters in tumor characterization.
Diagnostic Outcome Measure	Up to December 31, 2025.	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).
Quantitative outcome	Up to December 31, 2025.	Correlation of quantitative \[18F\]FET PET metrics with imaging biomarkers from other modalities and added value of kinetic modeling.

Contacts

CONTACTChiara Catalano, PhD

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

CONTACTAlexandra Lazar, Dr.

lazar.alexandra@hsr.it;

Outcome results