[18F]FET PET for Characterization of Progressive or Recurrent Glioma From Treatment Related Changes
NCT ID: NCT07238322
Last Updated: 2026-01-20
Study Results
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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ENROLLING_BY_INVITATION
400 participants
OBSERVATIONAL
2025-08-01
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
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
Imaging as part of routine care
Interventions
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18F(FET)PET
Imaging as part of routine care
Eligibility Criteria
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Inclusion Criteria
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.
ALL
No
Sponsors
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Telix Pharmaceuticals (Innovations) Pty Limited
INDUSTRY
Responsible Party
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Locations
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University of California, San Francisco
San Francisco, California, United States
University Hospital Essen
Essen, , Germany
Universityhospital Tuebingen
Tübingen, , Germany
The University Medical Center Utrecht
Utrecht, , Netherlands
Countries
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Other Identifiers
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18F-TLX101-005
Identifier Type: -
Identifier Source: org_study_id
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