CompletedPhase 2

Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms

United States143 participantsStarted 2018-10-29

Plain-language summary

This phase II trial studies how well F-18 fluoroethyltyrosine (fluoroethyltyrosine) works in detecting tumors in participants with intracranial tumors that have come back. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize the grade of glial neoplasms. Imaging agents such as FET can help oncologist to see the tumor better during a positron emission tomography (PET) scan.

Who can participate

Age range

3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 3 years. * Presence or suspicion of intracranial neoplasm in two populations. * Population 1: Patients after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on magnetic resonance imaging (MRI). Three sub-populations will be considered: * Recurrent metastatic lesions. * Recurrent high-grade gliomas (grades 3 and 4). * Recurrent low-grade gliomas (grades 1 and 2). * Population 2: Patients prior to primary treatment with planned biopsy or surgical resection. Exclusion Criteria: * Patient with known incompatibility to PET or computed tomography (CT)/MRI scans. * Patient unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation. * Sedation or anesthesia can be used for patients who cannot tolerate the exam.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial used a special PET scan called FET PET to look at brain tumors — how does this imaging approach compare to the standard MRI I'm already getting, and could the results change how my tumor is diagnosed or monitored?
2Since this was a Phase 2 trial that has already completed, has the data been published yet, and what did it show about how accurately FET PET could detect or rule out tumor activity in people with gliomas like mine?
3My diagnosis involves a glioma — would the findings from this FET PET study be relevant to decisions about my specific grade or type, given that the trial included everything from low-grade gliomas to recurrent glioblastoma?
4Could FET PET imaging help distinguish between my tumor actually growing versus treatment-related changes on the scan, which I've heard can look similar on standard imaging?
5Are there other ongoing trials or clinical settings where FET PET is still being studied or used, and is this something worth pursuing as part of my care even though this particular trial is no longer enrolling?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity of Fluoroethyltyrosine (FET) PET using a composite standard of truth (CSOT) (subject-level)

Timeframe: Up to 6 months

Specificity of FET PET using a CSOT (subject-level)

Timeframe: Up to 6 months

Trial details

NCT IDNCT04044937

SponsorThomas Hope

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-31

View on ClinicalTrials.gov More Intracranial Neoplasm trials