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 range3 Years

SexALL

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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.

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