Clinical trial · Observational
[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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Retrospective Study | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F(FET)PET | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- 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.
- interventionNames
- Diagnostic Test: 18F(FET)PET
Primary outcomes (1)
- measure
- Primary Objective
- timeFrame
- 4 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
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