Clinical trial · Interventional
(68^Ga)-GaPSMA-11 PET/MR-imaging of Malignant Intra-axial Brain Tumors
[68Ga] Ga-PSMA-11 PET/MR-imaging of Malignant Intra-axial Brain Tumors; Primary Assessment of PSMA Expression, Optimization of Compound Delivery and Determination of Theranostic Potential
- 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)
PSMA is a transmembrane protein specifically expressed in the vascular endothelium of malignant brain tumors, most notably glioblastoma and not in healthy brain parenchyma. It has been shown to be involved in (neo)angiogenesis and endothelial cell invasion. By means of 68Ga-labeled PSMA ligands, investigators are able to non-invasively visualize/quantify PSMA expression in glioblastoma (neo)vasculature in vivo by means of PET. The primary aim of this study is to confirm PSMA as suitable diagnostic and potential theranostic target in patients with intra-axial brain tumors by means of \[68Ga\]Ga-PSMA-HBEC-CC (\[68Ga\]Ga-PSMA-11) PET. The secondary aim is to assess whether uptake is increased with intra-arterial injection in those tumors that show uptake after intravenous injection of \[68Ga\]Ga-PSMA-11.
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 |
|---|---|---|---|
| Malignant Brain Tumors | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intra-arterial injection | Procedure | — | UNRESOLVED |
| Radiopharmacon Contrast agent | Other | — | UNRESOLVED |
| synchronous PET/MRI scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- intra-arterial injection of [68Ga]Ga-PSMA-11
- description
- eligible for intra-arterial injection (age \>18 years) with enhancing glioma or brain metastases eligible for (re-)resection.
- interventionNames
- Procedure: intra-arterial injection
- Device: synchronous PET/MRI scan
- Other: Radiopharmacon Contrast agent
Primary outcomes (4)
- measure
- tumor SUV (upon intravenous and intra-arterial injection),
- timeFrame
- 1 day
- description
- tumor SUV (upon intravenous and intra-arterial injection
- measure
- SUV tumor-to-background ratio
- timeFrame
- 1 week
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Radiologically presumed/histologically confirmed. * glioma (grade II-IV) showing enhancement on post-contrast MRI * brain metastases * Planned for (re-)resection * Age \> 18 years old * Good clinical condition (Karnofsky performance status score \>70) * Ability and willingness to provide written informed consent Exclusion Criteria: * Impaired renal function: eGFR (MDRD) \<30 ml/min/1,73 m2 * Impaired liver function :AST and ALT \> 2.5 8 ULN * Karnofsky Performance score of less than 70 * Previous other malignancies, except for any previous malignancy which was treated with curative intent more than 3 years prior to enrollment, and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix * Known history of cerebrovascular disease (e.g. ischemic stroke, cerebral hemorrhage) * Severe claustrophobia prohibiting PET/MRI scanning * A neurologic or psychiatric condition impairing judgement, making adequate informed consent impossible * Any psychological, familial, sociological or geographical condition hampering participation Contra-indications for PET imaging * Pregnancy or lactation * Known allergic reaction to therapeutic radiopharmaceuticals * Contra-indications for MR imaging: * Metal implants or fragments of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field: * metal plates, wires, screws or rods * surgical (brain) clips or staples * metallic fragments in or near eyes or blood vessels * metallic cardiac valve(s) * a cardiac implantable electronic device (pacemaker, wires, implantable cardioverter-defibrillator (ICD)) * eye implants * ear or cochlear implants * a drug pump implant * a nerve stimulator * dental fillings and bridges * artificial joints * penile implants * tubal ligation clips * non-removable piercing * tattoos containing metal traces * Known allergic reaction to gadolinium-based contrast agents Contra-indications for arterial catheterization: * Known local infection thrombus or distorted anatomy at the puncture site * Known severe peripheral vascular disease or femoral artery disease, which makes the femoral approach impossible * Known severe coagulopathy (spontaneous prolonged PT with an INR \> 2.5) * In case of the use of anticoagulation: an absolute contra-indication to temporarily stop or bridge the anti-coagulation. * Known severe thrombocytopenia (platelet count 50 x 109/L) * Allergic reaction to iodine containing contrast agent * A physical, neurologic or psychological condition preventing the patient to lay still for the duration of the procedure (± 2h)
References
Publications (1)
- DERIVEDPruis IJ, van Dis V, Maas SLN, Balvers RK, van den Bosch TPP, Segbers M, Veldhuijzen van Zanten SEM. PSMA radioligand uptake correlates with PSMA expression in high-grade glioma and brain metastasis: insights from a prospective PET-MRI guided multiregional biopsy study. Eur J Nucl Med Mol Imaging. 2025 Nov;52(13):4870-4881. doi: 10.1007/s00259-025-07338-4. Epub 2025 May 26. PMID 40414994