Clinical trial · Interventional
18F-Fluciclovine PET Imaging for Detecting High Grade Glioma Recurrence After Radiochemotherapy
NCT05479136CI-TRIAL-00061754DRARCHunknownPhase 3ClinicalTrials.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 study will examine whether positron emission tomography (PET) imaging with fluciclovine can reliably differentiate true progression from pseudoprogression months earlier than the conventional MRI methods.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Grade III or Grade IV Glioma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET imaging with 18F fluciclovine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET study
- description
- Single intravenous administration of 18F fluciclovine for PET Scan
- interventionNames
- Drug: PET imaging with 18F fluciclovine
Primary outcomes (1)
- measure
- Brain tumor progression
- timeFrame
- 20 weeks
- description
- whether fluciclovine PET, a commercially available tracer, provides A reliable measure of brain tumor progression months earlier than conventional MRI.
Secondary outcomes (1)
- measure
- PET uptake and dynamic susceptibility contrast (DSC) perfusion
- timeFrame
- 20 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Greater than 18 years of age 2. Histological diagnosis of primary WHO grade III or IV glioma 3. Completed standard radiotherapy 4. Undergoing or completed standard chemotherapy (or other therapies) 5. Enlarging or new contrast-enhancing mass suspicious for progression/recurrence (at least 10mm in one direction) 6. Subjects must agree to take adequate pregnancy preventions from the time of consent until 24 hrs after the 18F-fluciclovine injection. 7. Willing and able to provide written informed consent in compliance with the regulatory requirements. If a subject is unable to provide written informed consent, written informed consent may be obtained from the subject's legal representative Exclusion Criteria: 1. Simultaneous participation in other interventional trials which could interfere with this trial. 2. Inability to undergo a MRI or PET scan (claustrophobia, non-MRI compatible pacemaker, renal insufficiency, known allergy to MRI contrast agent or fluciclovine tracer) 3. Subjects who are pregnant or lactating or who suspect they might be pregnant.
References
Publications (0)
Data not yet available
No reference posted for this study.