Brain TumorsFET-BRAIN-DXNCT07599917
Diagnostic Performance and Quantitative Analysis of [18F]FET PET in Brain Tumours
An observational study of Brain Tumors, run by IRCCS San Raffaele.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumors
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- . Pregnancy or breastfeeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Alexandra Lazar, Dr. contact
About this study
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
- Medical subject headings
- Brain Neoplasms, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with brain tumors | Patients with gliomas, brain metastases and meningiomas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective analysis of data acquired up to December 31, 2025.
Secondary outcomes (5)
Secondary Outcome Measure
Quantification and clinical utility of static [18F]FET PET parameters in tumor characterization.
Measured: 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).
Measured: 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.
Measured: Up to December 31, 2025.
Secondary Outcome Measure
Quantification and clinical utility of dynamic [18F]FET PET parameters in tumor characterization
Measured: Up to December 31, 2025
Secondary Outcome Measure
Quantification and clinical utility of kinetic and parametric [18F]FET PET in tumor characterization
Measured: Up to December 31, 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599917
- Sponsor's protocol ID
- FET-BRAIN-DX
- Acronym
- FET-BRAIN-DX
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance and Quantitative Analysis of [18F]FET PET in Brain Tumours
- ClinicalTrials.gov ID
- NCT07599917
- Acronym / sponsor ID
- FET-BRAIN-DX / FET-BRAIN-DX
- Conditions
- Brain Tumors
- Keywords
- FET PET, Brain Tumors, Meningioma, Diagnostic Accuracy, Dynamic PET Imaging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with brain tumors | – | –Patients with gliomas, brain metastases and meningiomas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- . Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Secondary Outcome Measure
Time frame: Up to December 31, 2025.
Diagnostic Outcome Measure
Time frame: Up to December 31, 2025.
Quantitative outcome
Time frame: Up to December 31, 2025.
Secondary Outcome Measure
Time frame: Up to December 31, 2025
Secondary Outcome Measure
Time frame: Up to December 31, 2025.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Lazar, Dr. contact
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumors, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Catalano, PhD (+39 0226433639, catalano.chiara@hsr.it; ricercamednuc@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: Retrospective analysis of data acquired up to December 31, 2025.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.