Clinical trial · Interventional
Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin
NCT05896449CI-TRIAL-00067029completedN/AClinicalTrials.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)
The aim of this study was to analyse usefulness of \[68Ga\]Ga-PSMA-11 PET/CT scans in preoperative differentiation between HGG and LGG in patients with suspicion of a tumor of glial origin in previously performed imaging examinations. The PET/CT scan will be compared with postoperative histopathological results and with additional immunohistochemical staining for PSMA expression.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma Glioblastoma Multiforme | — | UNRESOLVED | — |
| Glioma, Malignant | Malignant Glioma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-PSMA-11 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET/CT before surgery
- description
- \[68Ga\]Ga-PSMA-11 PET/CT before surgery
- interventionNames
- Diagnostic Test: [68Ga]Ga-PSMA-11 PET/CT
Primary outcomes (1)
- measure
- PET/CT vs histopathological diagnosis
- timeFrame
- through study completion, an average of 1.5 year
- description
- Comparison of the incidence of positive preoperative \[68Ga\]Ga-PSMA-11 PET/CT results with the final histopathological diagnosis based on the 5th edition of the WHO (World Health Organization) Classification of Tumours of the Central Nervous System (2021). The PET scan in this regard will be evaluated qualitatively - in terms of finding accumulation in the projection of the brain tumor (positive result) and lack of accumulation in the projection of the brain tumor (negative result). The histopathological diagnosis will take into account the subtypes of the tumor according on the 5th edition of the WHO (World Health Organization) Classification of Tumours of the Central Nervous System (2021) - including the histopathological examination and the genetic diagnosis - adult-type diffuse gliomas comprise of three distinct types: Astrocytoma, IDH-mutant, Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, and Glioblastoma, IDH-wildtype
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * primary lesion found in CT/MRI with radiological features of glial neoplasm * untreated disease, planned surgery * negative medical history of other neoplastic diseases * age over 18 * informed, voluntary consent to participate in the study Exclusion Criteria: * pregnant women, breastfeeding women * persons with a known allergy to PSMA * age under 18 * patient's lack of cooperation
References
Publications (1)
- DERIVEDPelka K, Koczyk K, Koperski L, Dziedzic T, Nowak A, Krolicki L, Kunert P, Kunikowska J. Imply on diagnosis and early prognosis of preoperative [68Ga]Ga-PSMA-11 PET/CT in patients with suspected brain tumours of glial origin. Sci Rep. 2025 Jan 2;15(1):214. doi: 10.1038/s41598-024-84036-5. PMID 39747932