Clinical trial · Interventional
Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms
Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
NCT04044937CI-TRIAL-00105289UC-GlioFETcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 phase II trial studies how well F-18 fluoroethyltyrosine (fluoroethyltyrosine) works in detecting tumors in participants with intracranial tumors that have come back. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize the grade of glial neoplasms. Imaging agents such as FET can help oncologist to see the tumor better during a positron emission tomography (PET) scan.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intracranial Neoplasm | Intracranial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Low Grade Glioma | Low Grade Glioma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Recurrent WHO Grade III Glioma | WHO Grade 3 Glioma | CURATED_BROADER | 0.78 |
| Recurrent World Health Organization (WHO) Grade II Glioma | Brain Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F-18 Fluoroethyltyrosine (FET) | Drug | — | UNRESOLVED |
| Positron Emission Tomography (PET) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Population 1: Intracranial neoplasms (glial or metastatic disease)
- description
- Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging (e.g., MRI) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients.
- interventionNames
- Drug: F-18 Fluoroethyltyrosine (FET)
- Procedure: Positron Emission Tomography (PET)
- type
- EXPERIMENTAL
- label
- Population 2: Suspected glial neoplasms
- description
- Participants with suspected glial neoplasms (Grade 2-4) planning to undergo a non-investigational biopsy or surgery prior to non-investigational, primary treatment (radiation therapy and/or surgery) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes. Repeat FET PET will be offered to adult patients.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
Show eligibility criteria text
Inclusion Criteria:
* Age \> 3 years.
* Presence or suspicion of intracranial neoplasm in two populations.
* Population 1: Patients after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on magnetic resonance imaging (MRI). Three sub-populations will be considered:
* Recurrent metastatic lesions.
* Recurrent high-grade gliomas (grades 3 and 4).
* Recurrent low-grade gliomas (grades 1 and 2).
* Population 2: Patients prior to primary treatment with planned biopsy or surgical resection.
Exclusion Criteria:
* Patient with known incompatibility to PET or computed tomography (CT)/MRI scans.
* Patient unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
* Sedation or anesthesia can be used for patients who cannot tolerate the exam.References
Publications (0)
Data not yet available
No reference posted for this study.