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NCT Number: NCT07599917

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Primary outcome

    Time frame: 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 outcomes

  1. Secondary Outcome Measure

    Time frame: Up to December 31, 2025.

    Quantification and clinical utility of static [18F]FET PET parameters in tumor characterization.

  2. Diagnostic Outcome Measure

    Time frame: 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).

  3. Quantitative outcome

    Time frame: Up to December 31, 2025.

    Correlation of quantitative [18F]FET PET metrics with imaging biomarkers from other modalities and added value of kinetic modeling.

  4. Secondary Outcome Measure

    Time frame: Up to December 31, 2025

    Quantification and clinical utility of dynamic [18F]FET PET parameters in tumor characterization

  5. Secondary Outcome Measure

    Time frame: Up to December 31, 2025.

    Quantification and clinical utility of kinetic and parametric [18F]FET PET in tumor characterization

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Lazar, Dr.

CONTACT

[email protected];

Chiara Catalano, PhD

CONTACT

[email protected]; [email protected]

+39 0226433639

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Acronym: FET-BRAIN-DX

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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