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OpenTrials
Completed

NCT Number: NCT07238322

[18F]FET PET for Characterization of Progressive or Recurrent Glioma From Treatment Related Changes

This study is designed to prospectively analyze [18F]FET PET image data obtained retrospectively in the routine clinical care of glioma patients. The study will analyse the data from participants with grade (1-4) glioma after primary treatment according to local clinical practice and with suspicion of progression/recurrence on magnetic resonance imaging (MRI).

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Key information

Who can participate

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

Inclusion criteria

  • Signed patient informed consent with secondary use of data permitted. Pediatric patients (<18 years of age) will provide assent along with parental/legal guardian /caregiver consent
  • Male or Female of any age at the time of [18F]FET PET imaging. While there is no age restriction, it is expected that enrollment of patients ≤ 3 years old will be rare due to the very low incidence of glioma in this age group.
  • Documented histologic diagnosis or clinical suspicion of glioma (Grades 1-4) based on local clinical assessment.
  • Underwent [18F]FET PET imaging as part of routine clinical care after completion of primary treatment (surgery, radiation therapy, and/or chemotherapy).
  • Evidence of radiographic suspicion of recurrence or progression on MRI at the time of [18F]FET PET imaging.
  • The adult patient, 18 years of age or older, has received nominal injected dose of 4 to 7 mCi (148 - 259 MBq ) of [18F]FET per imaging time point.
  • The pediatric patients, 0-17 years old, must have received a pediatric dose adjusted based upon the patient's body weight.

Exclusion criteria

Participants will be excluded if they did not meet any of the inclusion criteria or institutional requirements for participation.

  • Did not meet all inclusion criteria.
  • Did not undergo [18F]FET PET imaging as part of routine clinical care.
  • Imaging data or associated clinical information is incomplete, non-evaluable, or of insufficient quality for analysis.
  • Any institutional or regulatory requirement that precludes data sharing or inclusion in retrospective research studies.

Treatment and study plan

18F(FET)PET

Diagnostic Test

Imaging as part of routine care

Primary outcomes

  1. Primary Objective

    Time frame: 4 months

    The performance of [18F]FET PET in its ability to differentiate between benign treatment-related changes (TRC) and recurrent glioma (Grades 1-4) in comparison to a composite standard of truth (CSOT) will be evaluated and sensitivity and specificity evaluated.

Sponsors and collaborators

Lead sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Industry

Registry information

Official study title

An Assessment of the Efficacy of Floretyrosine F 18 ([18F]FET) Positron Emission Tomography (PET) for Characterization of Progressive or Recurrent Glioma From Treatment Related Changes

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
May 15, 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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