Clinical trial · Interventional
Establishing Radiolabelled PSMA as a Target for Glioma Treatment
Dosimetry and Immunohistochemistry Study to Establish Radiolabelled PSMA as a Potential Target in Glioma Treatment
NCT05263466CI-TRIAL-00059020not yet recruitingN/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)
A study is being performed to observe whether a novel type of brain imaging using a technique called PET-MRI may provide useful information in the 'mapping' of adult primary brain tumours. It employs a radiolabelled molecule targeting a particular molecule called PSMA which is hypothesised to be a marker of aggression in primary brain tumours. 'Mapping' of the concentration and distribution of this molecule within brain tumours via PET-MRI may provide vital clinical information regarding the extent and timing of treatment.
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 |
|---|---|---|---|
| Glioma, Malignant | Malignant Glioma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brain tumour biopsy | Procedure | — | UNRESOLVED |
| PET-MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Brain tumour patients
- description
- Patients will be those undergoing routine care of primary brain tumours. Study group patients will undergo additional PET-MRI examination and biopsies in addition to the standard of care.
- interventionNames
- Diagnostic Test: PET-MRI
- Procedure: Brain tumour biopsy
Primary outcomes (1)
- measure
- Correlation of the PET-MRI PSMA signal intensity (arbitrary units) and glioma protein concentration (g/L) in a 1 x 1 x 1 cm region of interest (R value)
- timeFrame
- 5 years
- description
- PET-MRI signal will be recorded from different regions of interest within a glioma where stereotactic surgical biopsies taken and protein concentration determined.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals of 18 years or older * Referred for surgery (resection or biopsy) of presumed high grade primary brain tumour (based on imaging features of aggression e.g. perfusion imaging, diffusion restriction etc.). As standard, all patients will have had a full body CT and other investigations to rule out metastatic disease (this has a very high negative predictive value). * Written informed consent Exclusion Criteria: * Patient already enrolled in a drug trial * Contra-indication for MRI contrast * Contra-indication for radiotracer * Inability to give consent * Patient is pregnant or planning to become pregnant
References
Publications (4)
- BACKGROUNDLouis DN, Wesseling P, Aldape K, Brat DJ, Capper D, Cree IA, Eberhart C, Figarella-Branger D, Fouladi M, Fuller GN, Giannini C, Haberler C, Hawkins C, Komori T, Kros JM, Ng HK, Orr BA, Park SH, Paulus W, Perry A, Pietsch T, Reifenberger G, Rosenblum M, Rous B, Sahm F, Sarkar C, Solomon DA, Tabori U, van den Bent MJ, von Deimling A, Weller M, White VA, Ellison DW. cIMPACT-NOW update 6: new entity and diagnostic principle recommendations of the cIMPACT-Utrecht meeting on future CNS tumor classification and grading. Brain Pathol. 2020 Jul;30(4):844-856. doi: 10.1111/bpa.12832. Epub 2020 Apr 19. PMID 32307792
- BACKGROUNDWernicke AG, Edgar MA, Lavi E, Liu H, Salerno P, Bander NH, Gutin PH. Prostate-specific membrane antigen as a potential novel vascular target for treatment of glioblastoma multiforme. Arch Pathol Lab Med. 2011 Nov;135(11):1486-9. doi: 10.5858/arpa.2010-0740-OA. PMID 22032578
- BACKGROUNDUnterrainer M, Niyazi M, Ruf V, Bartenstein P, Albert NL. The endothelial prostate-specific membrane antigen is highly expressed in gliosarcoma and visualized by [68Ga]-PSMA-11 PET: a theranostic outlook for brain tumor patients? Neuro Oncol. 2017 Nov 29;19(12):1698-1699. doi: 10.1093/neuonc/nox172. No abstract available. PMID 29045711
- BACKGROUNDAbou D, Benabdallah N, Jiang W, Peng L, Zhang H, Villmer A, Longtine MS, Thorek DLJ. Prostate Cancer Theranostics - An Overview. Front Oncol. 2020 Jun 5;10:884. doi: 10.3389/fonc.2020.00884. eCollection 2020. PMID 32582550