Diagnostic Performance and Quantitative Analysis of [18F]FET PET in Brain Tumours
ConditionBrain Tumors
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
. Pregnancy or breastfeeding
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
69 Participants
are grouped into 1 trial groupGroup A: Patients with brain tumors
Trial outcomes
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.
Time frame
Retrospective analysis of data acquired up to December 31, 2025.Secondary outcomes
1
Secondary Outcome Measure
Quantification and clinical utility of static \[18F\]FET PET parameters in tumor characterization.
Time frame
Up to December 31, 2025.2
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).
Time frame
Up to December 31, 2025.3
Quantitative outcome
Correlation of quantitative \[18F\]FET PET metrics with imaging biomarkers from other modalities and added value of kinetic modeling.
Time frame
Up to December 31, 2025.4
Secondary Outcome Measure
Quantification and clinical utility of dynamic \[18F\]FET PET parameters in tumor characterization
Time frame
Up to December 31, 2025Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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