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

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

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).

Study Overview

• Status: Completed
• Conditions: Glioma; Brain Neoplasms; Retrospective Study
• Intervention / Treatment: Diagnostic test: 18F(FET)PET

• Study Type: Observational
• Enrollment (Actual): 253

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany
    • University Hospital Essen
  • Tübingen, Germany
    • Universityhospital Tuebingen
• Netherlands
  • Utrecht, Netherlands
    • The University Medical Center Utrecht
• United States
  • California
    • San Francisco, California, United States, 94107
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients who are enrolled in the study will be included in the FAS.

Description

Inclusion Criteria:

1. 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
2. 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.
3. Documented histologic diagnosis or clinical suspicion of glioma (Grades 1-4) based on local clinical assessment.
4. Underwent [18F]FET PET imaging as part of routine clinical care after completion of primary treatment (surgery, radiation therapy, and/or chemotherapy).
5. Evidence of radiographic suspicion of recurrence or progression on MRI at the time of [18F]FET PET imaging.
6. 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.
7. 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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Retrospective review of patients with histologically confirmed or suspected glioma (Grades 1-4) who underwent [18F]FET PET imaging as part of routine clinical care following completion of primary treatment (surgery, radiation, and/or chemotherapy), and who demonstrated radiographic suspicion of progression or recurrence on conventional imaging.	Diagnostic test: 18F(FET)PET; Imaging as part of routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	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.	4 months

Collaborators and Investigators

• Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2025
• Primary Completion (Actual): January 23, 2026
• Study Completion (Actual): January 23, 2026

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Central Nervous System Neoplasms; Glioma; Brain Neoplasms
• Other Study ID Numbers: 18F-TLX101-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No