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

NCT ID: NCT07238322

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Retrospective Study Glioma Brain Neoplasms

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

18F(FET)PET

Intervention Type DIAGNOSTIC_TEST

Imaging as part of routine care

Interventions

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18F(FET)PET

Imaging as part of routine care

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.


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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Telix Pharmaceuticals (Innovations) Pty Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

University Hospital Essen

Essen, , Germany

Site Status

Universityhospital Tuebingen

Tübingen, , Germany

Site Status

The University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Countries

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United States Germany Netherlands

Other Identifiers

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18F-TLX101-005

Identifier Type: -

Identifier Source: org_study_id

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