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

NCT07238322 | Active Not Recruiting

• 1 other identifier: 18F-TLX101-005
• Study Type: observational
• Target: 400
• Locations: 3 countries
• Sites: 4

Brief Summary

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).

Conditions

Retrospective Study; Glioma; Brain Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

18F(FET)PET DIAGNOSTIC_TEST

Imaging as part of routine care

Group 1

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Telix Pharmaceuticals (Innovations) Pty Limited: lead

Study Sites (4)

University of California, San Francisco

San Francisco, California, 94107, United States

Location

University Hospital Essen

Essen, Germany

Location

Universityhospital Tuebingen

Tübingen, Germany

Location

The University Medical Center Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: November 20, 2025
• Study Start: September 22, 2025
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); NL (1); DE (2)